CANADA -- JUDGE APPROVES CLASS-ACTION LAWSUIT
FULL ARTICLE: http://www.timescolonist.com/life/health/b-c-judge-approves-class-action-lawsuit-over-erectile-dysfunction-link-to-drug-1.102568
- Men who suffered ongoing erectile dysfunction after taking prescription drugs to treat prostate problems and male pattern baldness will be able to pursue a class-action lawsuit against the drug maker, a B.C. judge has ruled.
- The lawsuit was brought by Michael Miller against Merck Frosst Canada, makers of Propecia and Proscar, two drugs that contain the medication finasteride.
- In its third quarter earnings report last November, Merck & Co. announced it had been named in 265 lawsuits in New York and New Jersey alone over the sexual side effects of Propecia.
POST-FINASTERIDE SYNDROME FOUNDATION -- GRANTED NONPROFIT STATUS BY IRS AS A PUBLIC CHARITY
FULL ARTICLE: http://www.pfsfoundation.org/news/the-post-finasteride-syndrome-foundation-is-granted-nonprofit-status-by-the-irs-as-a-public-charity/
|Dr. John Santmann, CEO of Post-Finasteride Syndrome Foundation, which offers hope for Propecia victims.|
"SOMERSET, N.J., March 18, 2013 – The Post-Finasteride Syndrome Foundation today announced that it has been granted 501(c)(3) status by the Internal Revenue Service.
According to IRS regulations, the nonprofit status is retroactive to July 15, 2012, meaning all donations made to the PFS Foundation on or after July 15, 2012 are tax-deductible in the United States. Donations made from outside the U.S. may also be tax-deductible, depending on local tax codes.
“We thank the IRS for classifying us as a public charity,” said PFS Foundation CEO Dr. John Santmann. “Though thousands of men worldwide are likely suffering from post-finasteride syndrome—with potentially millions more at risk of developing the condition in the coming years—only a handful of medical professionals recognize the symptoms. And even when they do, there are no effective treatments. Those will only come through research at the molecular level.
“Nonprofit status will allow us to put more dollars to work pursuing our core goal, which is funding research on the characterization, underlying biologic mechanisms and treatments of PFS,” added Dr. Santmann."
ABSTRACTS FROM 2013 PFS ROUNDTABLE DISCUSSION IN ITALY: NEUROSTEROIDS INHIBITED
FULL ARTICLES (PG. 93-99): http://www.dafml.unito.it/anatomy/panzica/neurosteroids/downloads/SNS13AbstractBook.pdf
The roundtable discussion at the 7th international steroids and nervous system meeting in Orbassano (TO), Italy, February 16th – 20th 2013, included scientific presentations and discussions amongst multiple medical researchers regarding the Post-Finasteride Syndrome.
As noted in the following conference abstracts (pg. 96/97) the data obtained showed significant changes in the neuroactive steroid patten present in cerebrospinal fluid and plasma of three post-finasteride patients:
NEUROACTIVE STEROID LEVELS IN POST-FINASTERIDE PATIENTS SHOWING PERSISTENT SEXUAL SIDE EFFECTS AND ANXIOUS/DEPRESSIVE SYMPTOMATOLOGY"… A possible hypothesis to explain depression symptoms after finasteride treatment might be impairment in the levels of neuroactive steroids .
To this aim, neuroactive steroids levels were evaluated in paired plasma and CSF samples obtained from 3 male patients who received finasteride for the treatment of androgenic alopecia and that after drug discontinuation still show long-term sexual side effects as well as anxious/depressive symptomatology.
Data obtained by liquid chromatography-tandem mass spectrometry show a general decrease of neuroactive steroid levels, and particularly of 5α-reduced metabolites of PROG and T in CSF and plasma of post-finasteride patients.
The present results confirm that an impairment of neuroactive steroid levels, associated to depression symptoms, is present in androgenic alopecia patients despite the discontinuation of the finasteride treatment.”
These results may plausibly explain persistent depressive symptoms commonly found in PFS patients, and are of great concern.Nonetheless, in the abstract on pg. 97 by Bortolato M. (et al.), the authors note they are investigating novel therapeutic approaches to counter finasteride-induced depressive effects, which is of particular interest:
- TOWARDS A CHARACTERIZATION OF THE MOLECULAR BASES OF THE BEHAVIORAL EFFECTS OF FINASTERIDE
"…In the quest to shed light on the mechanisms of finasteride, we have studied the proteomic effects of acute and prolonged administration of this drug in the brain of male rats.
The results of these studies point to changes in a number of key proteins implicated in steroidogenic metabolism, synaptic plasticity and GABAergic neurotransmission.
Based on these and other results, we are currently testing a number of novel therapeutic approaches to counter finasteride-induced depressive effects and explain its antidopaminergic actions.”
For future research updates and to donate towards research into persistent Finasteride side effects, please visit the Post-Finasteride Syndrome Foundation website at http://www.pfsfoundation.org
ISMP QUARTER WATCH REPORT: Finasteride (PROPECIA, PROSCAR) and possibly persistent sexual side effects
FULL ARTICLE (PG. 7): http://www.ismp.org/quarterwatch/pdfs/2012Q2.pdf
- In the 20 year history of finasteride (PROPECIA, PROSCAR) three important issues in drug safety can be seen: First, a drug that blocks a key cellular process in the body may have many complex and different effects that go far beyond the disease or condition for which it is intended.
- Second, while drugs are approved quickly based on short-term trials typically of a few months, it can take a decade or more to document key long-term benefits or side effects. In the meantime, millions of patients may be exposed to unknown risks and uncertain benefits.
- Third, persistent side effects — those that don’t resolve after a drug is stopped — are among the most elusive, difficult both to detect and to measure, and often overlooked.
- Our analysis of finasteride for male pattern baldness began with a signal for impaired sexual function in 2012 Q2.
- Of 61 serious adverse event reports for finasteride, 46 cases involved sexual problems.
- In 27 of these cases, the reports indicated possibly persistent side effects, meaning that they had not resolved at the time the report was submitted.
- The first FDA warning that finasteride might be associated with persistent side effects came 20 years after its initial approval. 
- ... it seems plausible that a drug that engenders enduring changes in the anatomy of the prostate and the pattern of hair growth might also makes changes in sexual desire and function that are also long lasting.
... Specific side effects included penile curvature, testicular pain, scrotal pain, gynaecomastia, male breast disorder, testicular atrophy, penile size reduced, and anorgasmia.
- Overall, 72% of the reports of a sexual problem were associated with the 1 mg male pattern baldness product; the remainder were for the 5mg product for BPH, or was not stated.
This signal for persistent sexual side effects in the adverse event data is consistent with more detailed published and FDA studies, and not rendered less likely by the clinical trials’ results.
Effects on sexual function are biologically plausible and clearly evident in several clinical trials...
PROPECIA LAWSUITS GROW BY DOUBLE-DIGITS AS MORE VICTIMS SUE MERCK
FULL ARTICLE: http://www.examiner.com/article/propecia-lawsuits-grow-by-double-digits-as-more-victims-sue-merck
|Mounting woes: Merck CEO
Ken Frazier (above) faces ever
more lawsuits from furious
For the second consecutive quarter, the number of individuals who have filed lawsuits against the pharma giant alleging "that they have experienced persistent sexual side effects following cessation of treatment" with the hair-loss medication (or with Proscar, the same drug, finasteride, to treat enlarged prostate) grew at a double-digit rate.
According to the company's quarterly report for the period ended Sept. 30, 2012, "approximately 265" product-liability lawsuits "involving a total of approximately 415 plaintiffs...have been filed against Merck."
That's a 32.5% rise in the number of lawsuits and a 27.5% rise in plaintiffs over the previous quarter, ended June 31, 2012.
Propecia profits, meanwhile, seem to be suffering in tandem. For the quarter ended Sept. 30, 2012, sales of the controversial drug tumbled about 7%, to $104 million, as compared to $112 million for the same period in 2011"
PROPECIA SHRINKS GENITALS OF ASPIRING YOUNG TEACHER, DECIMATES HOPES
FULL ARTICLE: http://www.examiner.com/article/propecia-shrinks-genitals-of-aspiring-young-teacher-decimates-hopes?cid=rss
"Merck claims its mission is 'to help
Credits: courtsey of John Peige
To the casual observer, Matthew Garner could pass as a poster boy for American goodness.What with his pursuit of a career as an elementary school teacher, part-time job as a hospital orderly, clean-scrubbed appearance and neighborly demeanor, you'd think you were chatting with a young Tom Hanks.
But interject Propecia into the picture and that idyllic image quickly morphs into a nightmare."Actually, worse than a nightmare," says Garner (not his real name).
"You wake up from nightmares and realize you're still in Kansas, so to speak. Now, every waking moment is weighed down by the realization that my physical, sexual and mental health may be permanently damaged.
"All because of Merck and its goddamn drug," adds the Michigan resident.
THE HAIR RAISING TRUTH ABOUT CURES FOR MALE BALDNESS
FULL STORY: http://www.dailymail.co.uk/home/moslive/article-2222978/Male-baldness-Drugs-affect-libido-13-hour-operations-hair-covered-membranes-fused-scalp.html
- The drug finasteride’s hair-saving qualities were discovered accidentally when patients taking the drug to shrink their prostates experienced almost no hair loss compared to men of the same age. Because of the drug’s ability to block DHT it is also used to help feminise male to female transsexuals (it also halts excess body hair.) But this powerful drug can cause powerful side effects.
- ‘Something in the order of five to ten per cent of guys who take these drugs, from hundreds of thousands of users, report side effects,’ says Dr Alan Jacobs, a New York-based neuroendochrinologist. 'Maybe a third of those keep these problems, and then another third of those people keep them for a long time.’
- Dr Jacobs explains that finasteride lowers testosterone, which can result in hypogonadism – a maelstrom of symptoms that include the loss of libido and erectile dysfunction. The other symptoms are fatigue, loss of joie de vivre and anxiety,’ he says.
- ‘If it goes on long enough you can feel like a eunuch. You can have problems with muscle growth and cardiac problems. It is not good to be hypogonadal for a man until you hit about 80.’
- Dr Jacobs points out that some patients who have experienced symptoms for up to ten years seemingly lose their sexual function.
- Anxiety resulting from these side effects can have a shattering effect on work and relationships. What compounds the problem further is that men seeking hair loss treatment may already have pre-existing anxiety issues.
- I ask him if as a balding man he would take finasteride himself? ‘No. As a physician I know the value of a healthy lifestyle. I also majored in philosophy and I think of hair as not very metaphysically important to your character or your health.’
POST-FINASTERIDE SYNDROME FOUNDATION SPONSORS PFS RESEARCH ROUNDTABLE IN ITALY
FULL ARTICLE: http://www.pfsfoundation.org/news/post-finasteride-syndrome-foundation-sponsors-pfs-roundtable-for-medical-researchers-at-international-meeting-on-steroids-and-the-nervous-system/
- The Post-Finasteride Syndrome Foundation is sponsoring a roundtable discussion on PFS at the University of Milan’s 7th International Meeting on Steroids and the Nervous System conference in Torino, Italy, Feb. 19, 2013.
- Titled “Effects of Finasteride Treatment on the Nervous System,” the event is being organized by Roberto Melcangi, associate professor at UM’s Institute of Endocrinology; and Giancarlo Panzica, head of the Anatomy, Pharmacology and Forensic Medicine Department at the University of Torino.
- Among the keynote speakers, in addition to Prof. Melcangi, will be Abdulmaged M. Traish, PhD, professor of biochemistry and urology at Boston University School of Medicine.
WOMAN STARTS PETITION TO 'RECALL PROPECIA FROM MARKET'
A California woman has started a petition to have Propecia removed from the market: http://www.change.org/petitions/take-propecia-off-the-market
On the petition page she notes:
"Thousands of men and even some women have been suffering from severe side effects because of this drug AND IT IS STILL ON THE MARKET.
Although the most significant are sexual side effects, victims also suffer greatly from mental and physical side effects that become more prominent and persistent after they discontinue taking Propecia. There is no clear way to reverse these side effects which appear to be long lasting if not permanent in many cases. Many who have taken Propecia have lost their marriages, jobs and some have committed suicide due to the damage this drug has done to their bodies.
One of my loved ones is a victim of this drug. It's painful to see how much he has to struggle just to make it through each day and do all the daily things that we take for granted. No doctors have been able to help him and he is struggling to pay for medical bills. He is only 23. Unlike many his age, he has to constantly worry about his health.
Please stand with us and join this petition; tell Merck to take this drug off the market and help those suffering from its side effects get the medical help and compensation that they need. This could have been you or someone close to you. THESE PEOPLE DESERVE JUSTICE AT THE LEAST."
RECENT MEDIA AWARENESS
- The Australian Financial Review - Looking at care with a critical eye
- The Sydney Morning Herald - Hair-loss Drug a Downer in the Bedroom
- Newstrack India - Hair-loss drug 'causes sexual side effects in men'
Waywire's special correspondent Baruch Shemtov investigates recent studies about the hair-loss prevention drug Propecia (Finasteride) and sexual dysfunction.
Dr. Darius Paduch of the Cornell Medical College department of Urology shares his thoughts on the controversial drug and persistent side effects.
|Dr. John Santmann, CEO of Post-Finasteride Syndrome Foundation, which offers hope for Propecia victims.|
AUGUST 2012 - BREAKING NEWS
NEW POST-FINASTERIDE SYNDROME FOUNDATION OFFERS HOPE TO PROPECIA VICTIMS
- The Post-Finasteride Syndrome Foundation today announced the launch of its website, PFSFoundation.org, which will help raise funds for medical research into treatments for post-finasteride syndrome (PFS), while promoting awareness of the condition.
- Financial contributions to the foundation can be made via PFSFoundation.org, which also houses published research, research goals, and media reports about PFS. To date, individual donors have promised hundreds of thousands of dollars in funding to the foundation, Dr. Santmann told The Examiner.
- Established in July 2012, the PFS Foundation is based in Somerset, N.J. The announcement of the PFS Foundation follows two new studies by Dr. Michael Irwig of George Washington University on the controversial medication's long-terms dangers.
|The Post-Finasteride Syndrome Foundation website can be found at www.PFSFoundation.org|
- The foundation also announced the election of Dr. John Santmann as CEO, Dr. Rosemary McGeady as general counsel, and Matthew Weintraub, R.N., as vice president.
- "From the increasing number of PFS cases being reported to the FDA, it's likely that we're just seeing the tip of the iceberg in terms of how many men have been rendered impotent by finasteride, let alone beset by other severe side effects that don't resolve themselves months and even years after quitting the drug," said Dr. Santmann, an emergency department physician by training, who earned his M.D. from Washington University School of Medicine and his B.A. from The Johns Hopkins University.
- "Now, with the foundation's website serving as a focal point for the scientific community, we aim to facilitate research at universities and hospitals in the U.S. and abroad," added Dr. Santmann. "Through these initiatives, we're seeking to identify the underlying biologic mechanisms of PFS and, hopefully, develop effective treatments."
PFS is characterized by sexual, neurological, hormonal and psychological side effects that persist in men who have taken the prescription drug finasteride to treat hair loss (under the brand name Propecia and generics), or enlarged prostates (Proscar and generics).
Among the symptoms endured by thousands of PFS victims across the globe are erectile dysfunction, genital shrinkage, Peyronie's disease, gynecomastia, loss of libido, severe depression and cognitive impairment.
RECENT MEDIA COVERAGE
|Federal ICE special agent ravaged by Propecia, stripped of badge and gun, calls for Merck CEO to come clean on hair loss drug's devastation side effects.|
- ICE AGENT RAVAGED BY PROPECIA, STRIPPED OF BADGE, HOLDS MERCK CEO RESPONSIBLE
If not for Propecia, Steven Rossello would still be playing a critical role in protecting America against terrorism.
- CASE SHAPING UP FOR LAWSUITS TARGETING MERCK'S BALDNESS DRUG PROPECIA
As continuing revelations detail the devastating side effects that Propecia has had on otherwise hundreds of healthy young men, lawsuits targeting Merck's
baldness drug have now been filed in every state of the union.
- PROPECIA LAWSUITS SKYROCKET AS SALES OF MERCK'S RISKY BALDNESS DRUG DECLINE
Despite Justin Bieber's recent plea for Prince William to pop Propecia, the perilous hair-loss drug is losing market share at a double-digit pace—while gaining
furious customers at a triple-digit clip.
- CNN -- KEVIN MALLEY SUING MAKERS OF HAIR LOSS DRUG, PROPECIA
AUGUST 2012 - NEW STUDY PUBLISHED -- "DEPRESSIVE SYMPTOMS AND SUICIDAL THOUGHTS AMONG FORMER USERS OF FINASTERIDE WITH PERSISTENT SEXUAL SIDE EFFECTS"
Dr. Michael Irwig at George Washington University has published a new study on depressive symptoms and suicidal thoughts in former users of Finasteride with persistent sexual side effects.
- Pharmacovigilance is the science relating to identifying, monitoring, and effectively reducing adverse drug reactions. When a drug comes to market, it is often studied in only a thousand patients or less, as in the case of finasteride. 1,2 Less common adverse effects of a medication may be uncovered only in the postmarketing phase after many thousands of patients have been exposed to the medication.3
- In April 2012, the US Food and Drug Administration announced changes to the professional labels for Propecia (finasteride 1 mg) to expand the list of persistent sexual adverse events reported.8 ... In December 2010, the product labeling for Propecia in the United States was updated to include the side effect of depression.13
- In a group of 61 otherwise healthy former users of finasteride who developed persistent sexual side effects, depressive symptoms were present and categorized as mild in 11% of users, moderate in 28% of users, and severe in 36% of users. Suicidal thoughts were present in 39% of former finasteride users, and an additional 5% chose the statement “I would like to kill myself.”
- The corresponding rates of depressive symptoms and suicidal thoughts were significantly lower in a control group of young men with male pattern hair loss who had not used finasteride and who did not have any current or past psychiatric conditions or use of psychiatric medications.
- A plausible biological mechanism to explain the association between finasteride and depression lies with neuroactive steroids, neuromodulators that are synthesized in the central nervous system itself and that are also transported to the brain from the gonads and adrenal glands.
- It turns out that finasteride crosses the blood-brain barrier and blocks the enzyme 5α-reductase, which reduces the concentrations of multiple neuroactive steroids derived not only from testosterone, but also from progesterone and deoxycorticosterone.... reduced concentrations of neuroactive steroids are associated with depression in several human studies.
- Although the effects of finasteride in the human brain are poorly understood, clinicians, as well as potential finasteride users, should be aware of the serious potential risks of this medication, especially as it is being used cosmetically to alter a normal age-related process. This is the first study to document suicidal thoughts in (former) users of finasteride.
- ABC News – Hair-Loss Drug Propecia Linked to Depression
- Fox News – Hair Loss Drug May Cause Severe Depression
- Los Angeles Times – Propecia For Baldness Can Cause Depression Long After Use Stops
- Huffington Post – Former Users Of Baldness Drug Prone To Suicidal Thoughts, Says US Doctor
- PsychCentral – Men Who Used Propecia Risk Depression, Suicidal Thoughts
- ScienceBlog – Depressive Symptoms and Suicidal Thoughts in Former Finasteride Users
JULY, 2012 - NEW PAPER PUBLISHED -- "5α-REDUCTASES IN HUMAN PHYSIOLOGY: AN UNFOLDING STORY"
FULL TEXT PDF: http://aace.metapress.com/content/t02936j2760g6483/fulltext.pdf
Dr. Abdul Traish (PhD, MBA in the Department of Urology at Boston University School of Medicine) has published a new paper on the importance of 5-alpha reductase type 1, 5AR type 2 and the newly discovered 5AR type 3 enzyme, and the effects of 5AR inhibitors such as Finasteride (Propecia, Proscar) and Dutasteride (Avodart) on these enzymes and bodily processes.
- 5α-reductases are a family of isozymes that play a critical role in transformation not only of testosterone but also of progesterone, DOC, aldosterone and cortisol into a host of neuro-active steroids that regulate multitude of functions in human physiology.... the neuro-active steroid hormones modulate multitude of functions in human physiology encompassing regulation of sexual differentiation, neuro-protection, memory enhancement, anxiety, sleep and stress, among others.
- While the clinical use of 5α-reductases inhibitors was well established, the scope and the magnitude of the adverse side effects of such drugs especially on the central nervous systems is still unrecognized, due to lack of knowledge of the various physiological function of this family of enzymes, especially in the central nervous system.
- There is an urgent need to better understand the function of 5α-reductases and the role of neuro-active steroids in human physiology in order to minimize the potential adverse side effects of inhibitors targeting 5α-reductases to treat BPH and AGA.
- Until recently, the adverse effects of 5α -reductase inhibitor therapy were thought to be very minor and well tolerated (80, 81, 82). However, new information suggests that these drugs may impair sexual function including sexual desire, erectile and orgasmic function [Table 3](for review cf. 83, 84). Recent studies in animal models suggested that these agents alter penile tissue histo-architecture and nitric oxide synthase function in penile tissue and thus can contribute to erectile dysfunction (85, 86, 87).
- It is particularly important to note that in a subset of patients, the effects of these drugs are long lasting and may be irreversible (84). An association between use of these inhibitors and depression is also noted (88), suggesting potential adverse effect on the brain.
- A number of case reports have suggested that 5α-reductase inhibitors therapy is associated with angioedema ( 91); cataract and intraoperative floppy-iris syndrome (92), pseudoporphyria, (93),T cell–mediated acute localized exanthematous pustulosis (94) and gyncomastia and male breast cancer (28, 95).
- The recent introduced warnings on the drug labeling also suggests that increased awareness of the potential irreversible side effects of these agents [FDA].
JULY 12, 2012 - NEW STUDY PUBLISHED -- "PERSISTENT SEXUAL SIDE EFFECTS OF FINASTERIDE: COULD THEY BE PERMANENT?"
Dr. Michael Irwig at George Washington University has published a new study on persistent Finasteride side effects. This new 2012 study is a follow-up to his March 2011 study titled "Persistent Sexual Side Effects of Finasteride for Male Pattern Hair Loss".
- "In a group of 54 otherwise healthy former users of finasteride who developed persistent sexual side effects that lasted for at least 3 months, 96% continued to experience these effects when reassessed 9–16 months (mean 14 months) later, raising the possibility of permanent effects."
- "There is a solid and growing body of basic science evidence that finasteride reduces the concentrations of several neuroactive steroids that play a role in neurogenesis and neuronal survival."
- "To explain the long-term neurological effects of finasteride, it is possible that reduced concentrations of neuroactive steroids are affecting the plasticity of neuronal architecture in regions of the brain responsible for sexual function."
- "Another recently published study found that rats treated with finasteride for 4 weeks had a 26% reduction in the weight of their corpora cavernosa as compared with a control group . This finding is consistent with the reports of genital shrinkage reported by some of the human subjects in this study."
- "The most volunteered changes related to the urogenital system in terms of semen quality and decreased ejaculate volume, reduction in penis size, penile curvature or reduced sensation, fewer spontaneous erections, decreased testicular size, testicular pain, and prostatitis. Many subjects also noted changes to their mental abilities, sleeping patterns, and/or depressive symptoms. Many subjects reported a “disconnection” between the mental and physical aspects of sexual function."
- "The typical story of men with persistent sexual and other side effects is that they unsuccessfully seek help from various providers in multiple medical specialties. It is important for physicians to acknowledge with their patients the current limitations in medical knowledge, particularly as it relates to neuroscience. There is no known blood or imaging test to study or measure neuroactive steroids or their metabolites in different areas of the brain associated with sexual function."
- "Further valuable research could determine who would be susceptible to finasteride through genetic studies of polymorphisms of 5a reductase and the androgen receptor. Further research with validated instruments is needed to study the nonsexual persistent side effects associated with finasteride."
JUNE 12, 2012 - PROPECIA VICTIMS FURIOUS BOSLEY KNEW OF DRUG'S DANGERS BUT DID NOT WARN PATIENTS
Excerpts from the article:
- "When the Food and Drug Administration approved the hair-growth drug Propecia in 1997, a number of doctors and medical researchers voiced their strong concerns about the drug’s severe side effects. One outspoken critic was well-known hair-restoration expert L. Lee Bosley who publicly denounced Propecia as a "serious health concern" in the wake of its FDA approval—only to allow his doctors to enthusiastically recommend the medication to patients a few years later.
- On Dec. 24, 1997, Bosley Medical—which bills itself as "The World's Most Experienced Hair Restoration Experts" and today boasts some 70 offices in the U.S., Canada, Mexico and China—issued a news release via paid-distribution service Business Wire. Headlined "Supposed Miracle Baldness Cure Creates Serious Health Concerns Among Hair Restoration Professionals," that release (still housed on LexisNexis) quoted Dr. Bosley as saying of Propecia:
"The FDA has just approved a drug that has the capability to impair male sexual performance, creating the inability to achieve an erection [and] decreases libido... The potential side effects, especially the long-term side effects of the drug, should be the overriding concerns to both the users and the manufacturer."
- Dr. Bosley also said of Propecia (generic name: finasteride) that "the results attained during the clinical trials would immediately be dismissed as unacceptable by our standards." All of which is enormously ironic, say Bosley patients, particularly the assertion about Propecia being unacceptable by the standards of Dr. Bosley. For as shortly as three years after Dr. Bosley issued his stern warning of Propecia, Bosley Medical doctors began prescribing the risky drug.
Within a few months of starting on Propecia, [Julian] Parks says he developed excruciating pain in one testicle, which lasted two years. A few years later, while still on the drug—though at half-dose—he says he developed Peyronie's disease, a painful disorder characterized by the growth of fibrous scar tissue inside the penis, which often causes curvature of the erect organ. Parks, who says he previously had no major health concerns, finally quit the drug in 2006 after suffering other side effects. To this day, most of them have yet to resolve themselves.
Seven weeks after starting on finasteride, the previously healthy [Thomas] Schultz says he became extremely depressed and was beset by panic attacks. That while witnessing his genitals shrink to tiny proportions and grow completely numb. And though he quit the drug two weeks later, Schultz says his health rapidly worsened.
Among his side effects—which continue to afflict him to this day—have been loss of libido, impotence, breast enlargement, prostate pain, muscle aches, cognitive dysfunction, anhedonia and severe insomnia, as well as Peyronie's disease. Meanwhile, Schultz says he has consulted some of L.A.'s top urologists, neurologists and endocrinologists, all of whom have told him there's nothing they can do to help. When Schultz discovered that Dr. Bosley had issued a press release in 1997 warning of Propecia's dangers, he said, "I grew sick to my stomach at his betrayal of innocent, unsuspecting people like myself."
Known clinically as Post-Finasteride Syndrome, the condition that has ravaged Shultz, Parks and thousands like them around the globe is marked by sexual, neurological, hormonal and physical side effects—including impotence, Peyronie's disease, testosterone deficiency and depression—that do not resolve themselves after quitting Propecia."
MAY 21, 2012 - PARENTS OF PROPECIA SUICIDE VICTIM JOIN IN KEVIN MALLEY'S MERCK PROTEST
- Examiner.com: http://www.examiner.com/article/parents-of-propecia-sucide-victim-join-kevin-malley-s-merck-hunger-strike
- MyCentralJersey.com: Family of Montgomery suicide victim speak out against hair-loss drug Propecia
ER-physician John Santmann, father of Propecia suicide victim Randy Santmann, joins to support Kevin's Malley's hunger-strike protest at drug-maker Merck's headquarters.
John Santmann (center) attends demonstration outside Merck headquarters in Whitehouse Station on Monday.
His son killed himself in 2008 after experiencing side effects he believed were from the drug Propecia.
Photo Courtesy of Kevin Malley
MAY 16, 2012 - PROPECIA VICTIM LAUNCHES HUNGER STRIKE AT MERCK USA HEADQUARTERS
Protester Suffering Erectile Dysfunction, Career Loss, Breakup with Fiancee
- The Examiner.com has picked up the story, you can read it here.
- 2nd article: Kevin Malley says Merck hunger-strike targets Propecia’s horrific side effects
Photo credit: Kevin Malley
WHITEHOUSE STATION, N.J., May 16, 2012
A 30-year-old Las Vegas man whose life was devastated by Propecia has launched a hunger strike at Merck & Co.'s corporate headquarters,
in protest of the pharmaceutical giant's failure to acknowledge the hair-loss drug's role in causing a battery of persistent side effects, including sexual dysfunction.
Kevin Malley, a former public-health researcher from Las Vegas, who flew to New Jersey from his hometown on May 10, ceased eating on May 13 at 3 p.m., and plans to continue going without food indefinitely while camped across from One Merck Drive.
"I want Merck to see how their drug is destroying lives—and know that I'm just one of thousands of victims suffering across the globe," said Malley, who was prescribed Propecia last year by his doctor, and took the controversial medication for five months until suffering complete erectile dysfunction and loss of libido last winter.
"Even now, eight months after quitting Propecia, my sexual dysfunction has not resolved itself," added Malley. "I also suffered severe memory loss and disorientation, which made it nearly impossible to concentrate on my work."
As a result of his physical and psychological ailments, Malley resigned from his research position late last year. He has since taken a job as a waiter at a Las Vegas restaurant to make ends meet.
Meanwhile, he and his fiancee broke off their engagement when she learned that his sexual side effects appear to be permanent. And while trying to come to grips with his condition, Malley came across Propeciahelp.com, a support group for men suffering from persistent finasteride side effects. There, he encountered many other men suffering similar fates long after quitting the drug.
Malley has reported his case to the Food and Drug Administration via its MedWatch program. And in January he called Merck's Adverse Reporting hotline (800-444-2080), but the company, which enjoys annual Propecia sales of more than $440 million, told him, "We don't have any answers for you right now," he said.
Known clinically as "Post-Finasteride Syndrome" (and so called for Propecia's generic name, finasteride), the condition is marked by sexual, neurological, hormonal and physical side effects—including impotence, Peyronie's disease, testosterone deficiency and depression—that do not resolve themselves after quitting Propecia, and may be irreversible.
On April 11, the Food and Drug Administration ordered Merck to revise the labeling on Propecia to reflect mounting evidence that the medication can cause continued sexual dysfunction long after patients have stopped taking it. Of the 421 Propecia-related sexual dysfunction cases the FDA reviewed in its probe, 14 percent lasted longer than three months after patients discontinued the drug.
On April 20, according to a report in The Examiner, the FDA began widening its probe into Propecia, stating that the agency "will continue to vigilantly evaluate and analyze all reports that are available on finasteride and take regulatory actions as warranted."
The FDA has also been actively encouraging victims to submit reports about "all adverse reactions potentially caused by finasteride [including] cases of patients who developed Peyronie’s [disease], anxiety, panic attacks, cognitive dysfunction, chronic insomnia, muscle wasting and other persistent side effects."
APRIL 2012 - FDA MANDATES NEW SAFETY LABELING CHANGES FOR PROPECIA, PROSCAR
Following a lengthy safety review, the FDA has mandated that Finasteride (Propecia, Proscar) must carry additional warnings regarding the possibility of persistent sexual side effects.
- FDA Alert – Questions and Answers: Finasteride Label Changes
- Google News - FDA Announces Safety Label Changes to Finasteride – “Sexual side effects that continued after use of the medicines was stopped"
A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.
A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.
A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.
MARCH 2012 - FRANCE TF1 NEWS REPORT ON PERSISTENT PROPECIA SIDE EFFECTS
France's TF1 news station broadcast a report on persistent Propecia side effects, dangers of the drug, medical and health regulatory agency opinions, and interviews with men suffering from Post-Finasteride Syndrome -- persistent sexual, physical & neurological side effects that did not resolve after stopping Finasteride.
MARCH 2012 - HEALTH CANADA SAFETY ALERT & LABEL CHANGES
FINASTERIDE (Proscar, Propecia) and DUTASTERIDE (Avodart, Jalyn) MAY INCREASE RISK OF HIGH-GRADE PROSTATE CANCER
Following recent warnings & label changes from the FDA in the U.S., Health Canada has issued an alert that both Finasteride & Dutasteride may increase the risk of high-grade prostate cancer. Labeling has been updated for both drugs as a result.
- "Health Canada is informing health professionals and the public that the prescription drugs finasteride and dutasteride may be associated with an increased risk of developing a serious form of prostate cancer known as high-grade prostate cancer. High-grade prostate cancer is an aggressive type of prostate cancer that grows and spreads more quickly than low-grade prostate cancer."
- "The Canadian labels for the brand name drugs have been updated to inform about the increased risk of high-grade prostate cancer associated with these drugs and to emphasize that these drugs are not approved for the prevention of prostate cancer. Updates to the generics will follow."
MARCH - APRIL 2012 - EXAMINER.COM ARTICLES ON PERSISTENT PROPECIA SIDE EFFECTS
Columnist John Peige of the Baltimore Courts Examiner continues to write about the issue of persistent Finasteride side effects, the FDA's safety review of Propecia, and new FDA-mandated labeling changes for the drug.
- FDA widens Propecia probe; seeks men who’ve developed penis-curving Peyronie’s
- FDA takes lead as Propecia users become aware that they might be at serious risk
- New research finds finasteride (Propecia) causes penis shrinkage in rats
- FDA and Merck remain silent on Propecia safety while AdverseEvents speaks out
- FDA widens Propecia safety probe
- No answers from FDA or Merck on Propecia’s link to permanent sexual dysfunction
- Many questions, few answers as FDA conducts safety review of Propecia
- FDA reviewing safety of Propecia
- Urgency increases for FDA to provide guidance on Propecia’s safety
- FDA remains silent as debate intensifies over Propecia’s safety
- More men say lives are ruined as word spreads on Propecia’s side effects
- Merck pulls Propecia website content from Internet as public concern deepens
- Doctors link hair growth drug to sexual dysfunction, depression and cancer
FEB 2012 - ARTICLE: DOCTORS LINK HAIR GROWTH DRUG TO SEXUAL DYSFUNCTION, DEPRESSION AND CANCER
Columnist John Peige of the Baltimore Courts Examiner has written a scathing report on the issue of persistent Finasteride side effects, the medical community's lack of awareness of the problem, class action lawsuits, and the need for more research to find a cure.
- Doctors at two of this country’s leading medical schools have linked the hair growth drug Propecia to prolonged and possibly irreversible male sexual dysfunction, clinical depression, breast cancer and high-grade prostate cancer.
- The drug was approved by the FDA in 1997 to promote hair growth in men suffering from male pattern baldness. As devastating as these revelations are, millions of men who have been prescribed the drug Propecia have no idea that they may be at risk. Even worse, many doctors continue to prescribe Propecia unaware of the drug’s shocking side effects.
- Many men have undergone costly and time-consuming medical tests and treatments that will not detect or treat the source of the problem. They are told there is no problem. “In fact, patients have been told to see psychiatrists and psychologists because the problems were in their head,” says Dr. Irwig.
- While labeling on the medication in the U.S. recently warned about reported cases of persistent erectile dysfunction, there is no reference to the other sexual side effects being persistent. Other countries, including the United Kingdom and Sweden, several years ago documented persistent risks and required the drug’s maker to include them in labeling. It is not known exactly what causes these side effects.
- What is known is that unlike the vast majority of drugs, whose side effects cease when you stop taking them, Dr. Irwig explains that “finasteride is different because it can actually change the brain’s chemistry. The enzyme 5 alpha reductase is present in many areas of the brain. It is rare for a drug to have the capability to persistently change the brain's chemistry.”
- There is no known cure for men who have suffered from these severe symptoms that have destroyed their sexual function.
- Diagnosing these maladies is further complicated by the fact that the doctors who are prescribing Propecia are typically dermatologists and general practitioners. The doctors who are treating the symptoms of Propecia’s side effects are typically urologists and endocrinologists. Because of their diverse disciplines, they rarely have any cross interactions.
- The first class action lawsuits are now being filed. While individual lawsuits have been filed on the behalf of plaintiffs over the last several years, Dr. Irwig’s study and another recent review study on Propecia’s side effects in the Journal of Sexual Medicine by researchers at Boston University have now moved the discussion from an anecdotal one to one that has the credence of two of America’s most well-known medical schools.
- Two weeks ago, class action suits were filed in California and Florida joining those already filed in other states. More lawsuits are expected to be filed shortly in other jurisdictions.
NOV 2011 - MEN'S HEALTH MAGAZINE SPECIAL REPORT: "A HAIR-RAISING SIDE EFFECT"
- Check newsstands for the December 2011 Men's Health issue (Ashton Kutcher cover, article on pg. 102-105).
- Read FULL article online [7 pages]: http://www.menshealth.com/health/hair-raising-effect
Author Jim Thornton has written a Special Report on persistent Propecia side effects, the "Post-Finasteride Syndrome" and growing medical and legal awareness surrounding these issues.
- Charles decided to start taking Propecia, the only FDA-approved oral medication for male-pattern baldness. For the next 6 years he tolerated the drug fairly well. But he noticed one odd side effect: a random, intermittent decline in his sex drive. "I'd be with a sexy woman, and there was just no interest at all on my part," he recalls. "If anything, it was almost like I felt mild repulsion."
- ... he [Mark J.] suffered what some doctors have come to describe as an "endocrine system crash." Old symptoms returned and were more severe than ever, accompanied by strange new ones: hot flashes, extreme fatigue, and visible changes to the structure of his penis and scrotum, both of which literally began shrinking overnight. His libido vanished entirely. "Forget the fact that I wasn't very horny anymore," he says. "Now there was just no urge for sex whatsoever. I could be with the hottest girl on the planet and nothing would happen, either down there or in my head. It was as if my brain could no longer respond to anything erotic—visual or through touch."
- OVER A DOZEN PFS PATIENTS CONTACTED by Men's Health revealed remarkably similar symptoms to the ones described by Mark J. and Charles K. One man reported that since using and then quitting finasteride, he has been wandering through life in a state of constant "brain fog." Yet another views himself as an "asexual zombie."
- "Before our study, the published research indicated these were largely reversible side effects," says lead researcher Michael Irwig, M.D., an endocrinologist at George Washington University. But in this select population, over 90 percent were suffering from low sexual desire, erectile dysfunction, and decreased arousal—this after being finasteride-free for 40 months on average. One man had still not improved 11 years after taking his final pill. "It's a real irony," says Dr. Irwig. "Men took finasteride to stop or prevent hair loss and sometimes to improve their dating lives. And it actually ended up destroying their sexuality and self-esteem."
- In a 2011 study review in the Journal of Sexual Medicine, lead researcher Abdulmaged Traish, Ph.D., and his colleagues outlined extensive cause for concern. They concluded that animal and human studies strongly suggest that finasteride isn't limited to its target tissues but in fact can reduce DHT in many tissues, potentially affecting not only nerve-signaling pathways in the penis but also the ratio of male-to-female hormone levels circulating through a user's body. One study Traish cites found that men taking 1 milligram of finasteride daily had significantly higher levels of estradiol—the predominant female sex hormone—than men taking a placebo. Just as worrisome as the possible effects in body tissue is the growing evidence that finasteride can enter a man's brain and disrupt key chemicals therein.
As Traish's study review details, once finasteride reaches brain tissue it affects the production of more hormones than just DHT. At particular risk, Traish believes, are neurosteroids—brain chemicals that play a role in reducing anxiety, enhancing memory, regrowing brain cells, and helping us sleep.
There's yet another issue for men who already find themselves battling feelings of despair over their dissipated sex lives: At least two studies have shown that finasteride may cause the onset of depressive symptoms. And last year, researchers in Germany found that the drug inhibits the growth of new neurons in the brain's hippocampus ; this type of neurological "failure to thrive" has also been documented in people who suffer from clinical depression.
"The percentage of affected men may be small," acknowledges Traish, a researcher in the biochemistry and urology departments at Boston University's school of medicine, "but our research definitely concludes that PFS is real. For a subset of these men, the damage persists—maybe forever—even after they go off the drug. We don't fully understand why, but it is as if something shuts off biologically, and stays that way."
- To the surprise of virtually no one, anger over Merck's actions has bubbled its way into the legal system. At least two class-action lawsuits—one in the United States and one in Canada—have been filed on behalf of PFS patients seeking damages for the harm they say Propecia has caused them.
- Among other problems, Mark still suffers from a lack of nocturnal erections, genital numbness, and dulled orgasm. His libido has flatlined altogether, along with his zest for life. His once-defined musculature has given way to breast enlargement, atrophied arms, and female-pattern fat distribution in his hips—"this," he says, "despite keeping the same diet and exercise levels I had before ever taking the drug." He has recently joined a class-action suit—not for personal gain, he says, but in the hope that continuing pressure will convince Merck to fund further research into PFS.
- "What we do want," says Dr. Irwig, "is for patients and doctors alike to understand the potential risk of persistent problems that may not, in fact, be reversible when you stop this drug. Even if there's only one chance in 300 that it could happen to you, it's like playing with fire. If you're one of the 299 who don't have problems, that's great. But if you're the one who does, you're going to be kicking yourself for ever taking this medicine."
SEPT 2011 - MEN'S JOURNAL: "THE (NOT SO HARD TRUTH) ABOUT HAIR LOSS DRUGS"
In the October 2011 Men's Journal issue (Vol 20, #9, pg. 66-67), author Mickey Rapkin writes about the growing scrutiny regarding Propecia and hair loss drugs.
- "Jeff O. was 35 when his wife first confronted him about their increasingly anemic sex life. The couple had gone from almost daily romps to something like once every two months. "I had barely noticed," Jeff says. "I could have an erection. But it wasn't nearly as hard as before. ... After multiple visits to the doctor and a battery of tests, Jeff learned he was suffering from low testosterone, and the likely cause shocked him. "I'll be on hormone therapy for the rest of my life," he says, "because of Propecia."
- "Propecia was hailed as something of a miracle drug when it first hit the market in December 1997... at the time, pharmaceutical manufacturer Merck warned that a small percentage of all Propecia users could experience wilting erections and decreased libido. But to the millions of people who turned to Propecia to prevent hair loss, it was well worth the risk."
- "Now, new research shows that Merck may have underestimated the persistence of some of Propecia's side effects. ...If there's a smoking gun here, it might just be in Merck's own hand. According to a complaint filed in Florida, Merck expanded the warning on the product label to include the "persistence of erectile dysfunction after discontinuation" in the face of a study by Sweden's Medical Products Agency suggesting that Propecia could be a long-term sexual inhibitor. But the rewrite appeared just in Sweden. In March 2010 the fine print was also amended in Italy, but nothing about the possibility of lasting sexual side effects appeared in the U.S. until this spring..."
JULY 2011 - JOURNAL EDITORIAL: "AN OLD PROBLEM WITH A NEW CAUSE - 5 ALPHA REDUCTASE INHBITORS AND PERSISTENT SEXUAL DYSFUNCTION"
Dr. Irwin Goldstein, Editor-In-Chief of the Journal of Sexual Medicine, published a July 2011 editorial on the dangers of 5-alpha reductase inhibitors Finasteride and Dutasteride titled "An Old Problem with a New Cause—5 Alpha Reductase Inhibitors and Persistent Sexual Dysfunction"
- "...We are becoming more and more aware of persistent sexual health problems occurring as a result of the use of 5 alpha reductase inhibitors, finasteride, and dutasteride, in a subset of patients. What is even more alarming is that in addition to persistent sexual issues, there are persistent central cognitive issues and concerns of persistent depression."
- "I think of the frequent phone calls I receive from distressed men with varying degrees of hair loss who have used 5 alpha reductase inhibitors and now have newly manifested sexual and cognitive complaints that often persist despite discontinuation of the 5 alpha reductase inhibitor... In general, these patients feel deceived because of the lack of information warning them of potential sexual side effects. The majority feels strongly that the sexual problems are far worse than the hair loss concerns."
- "...At the end of the day, because sex steroid hormones are critical for genital organ structure and function, depriving young men of a critical sex steroid — dihydrotestosterone — affects sexual function."
- "... The 5 alpha reductase enzyme ALSO metabolizes progesterone to 5 alpha-dihydroprogesterone and deoxycorticosterone to 5 alpha-dihydrodeoxycorticosterone. And in the brain, the products of 5 alpha reductase inhibitors are transformed by another group of specific enzymes known as 3 alpha-hydroxysteroid dehydrogenases, which reduces 5 alpha-dihydrotestosterone to 3 alpha, 5 alpha-androstane 17b-diol (3a-diol), and 5 alpha-dihydroprogesterone to 3 alpha, 5 alpha-tetrahydroprogesterone (allopregnanolone). Similarly, 5 alpha-dihydrodeoxycorticosterone is further reduced to 3 alpha, 5 alpha-tetrahydrodeoxycorticosterone. " [THDOC]
- "Theoretically, these important neurosteroid derivatives are UNNECESSARILY LOWERED (collateral damage) by 5 alpha reductase inhibitors for hair loss. These reduced important neurosteroid derivatives are thought to function in the central nervous system with important physiological functions including modulation of gamma aminobutyric acid type A receptor, sigma receptor function, nicotinic acetylcholine receptor, voltage gated calcium channels, and synaptic and brain plasticity.
- "To translate into clinical terms, these physiological functions may impact mood, rhythm, stress, sleep, memory, anxiety, and sexual function."
June 2011 - FDA ALERT, LABEL CHANGES: FINASTERIDE MAY INCREASE RISK OF HIGH-GRADE PROSTATE CANCER
- FDA: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
"[6-9-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men."
- WebMD: Prostate Cancer Risk From BPH, Hair Loss Drugs
"The prostate drugs Proscar, Avodart, and Jalyn and the hair-loss drug Propecia add to the risk of high-grade prostate cancer, the FDA warns. All of the drugs must change their labels to warn of the risk, which unexpectedly appeared in two different large-scale clinical trials.
... The male hair-loss drug Propecia has the same active ingredient as Proscar, although at one-fifth the dose. But the FDA says Propecia should carry the same prostate cancer warning as Proscar."
MERCK USA - LABEL FOR PROPECIA & PROSCAR - UPDATES:
- PROPECIA Prescribing Information - http://www.merck.com/product/usa/pi_circulars/p/propecia/propecia_pi.pdf
Pg. 7 - Increased Risk of High-Grade Prostate Cancer with 5-Alpha Reductase Inhibitors
"... 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer."
- PROSCAR Prescribing Information - http://www.merck.com/product/usa/pi_circulars/p/proscar/proscar_pi.pdf
Pg. 18 - Increased Risk of High-Grade Prostate Cancer
"... Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, including PROSCAR, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer"
- PROSCAR Patient Information - http://www.merck.com/product/usa/pi_circulars/p/proscar/proscar_ppi.pdf
Pg. 2 - "PROSCAR may increase the chance of a more serious form of prostate cancer."
June 2011 - MERCK USA: PROPECIA LABEL UPDATE, REPORTS OF PERSISTENT ERECTILE DYSFUNCTION
The drug manufacturer recently updated the USA labeling for Propecia to include erectile dysfunction that continues after treatment, as a reported side effect from general Finasteride use:
- PG 2: http://www.merck.com/product/usa/pi_circulars/p/propecia/propecia_ppi.pdf
"In general use, the following have been reported: breast tenderness and enlargement; depression; allergic reactions including rash, itching, hives and swelling of the lips and face; problems with ejaculation; testicular pain; difficulty in achieving an erection that continued after stopping the medication; and, in rare cases, male breast cancer. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge. Tell your doctor promptly about these or any other unusual side effects."
This is a major change, in that it updates the USA labelling to reflect that of the European countries (Sweden, UK, Italy) which have had similar verbage for some time.
May 2011: NEWS & VIDEO REPORTS ON PERSISTENT FINASTERIDE SIDE EFFECTS
Recent media coverage, including one young man's tragic suicide.
FOX 9 News
"It’s a drug that promises to reverse hair loss for men, but is it worth the risk? As CBS 2′s Pam Zekman reports, some men say they have been devastated by a side effect of the baldness drug Propecia."
March 2011 - DR. ANDREW RYNNE WARNS AGAINST PROPECIA USE
Dr. Andrew Rynne is a GP based in Ireland, vasectomy surgeon, men's health specialist and author. In March 2011, he wrote another blog post on the dangers of Propecia use and persistent side effects.
- Benign Prostatic Hyperplasia
"...hardly a week goes by that I am not being approached by yet another young man recently prescribed Propecia as a “treatment” for male pattern baldness.
This drug has the capacity to obliterate their sexuality, not just for the time that they take the drug, but for all time.
This vanity treatment can and does condemn many young men to a life sentence of sexual anhedonia, without feeling, desire or function, to otter misery and despair for which, as yet, we have no treatment. If you would like to know more about this you can share in their pain on www.propeciahelp.com
I believe that potentially toxic medicine like this must be reserved for the indications for which it was first introducedand that is in the management of advanced prostate cancer with metastases. Here, as we all know, it can be life-saving or at any rate life-prolonging.
Using it to treat a benign condition like BPH is, in my view, at best questionable. Using it to treat a naturally occurring condition in men like male pattern baldness, is reckless in the extreme."
March 2011: GEORGE WASHINGTON UNIVERSITY - STUDY PUBLISHED: Persistent Sexual Side Effects of Finasteride for Male Pattern Hair Loss
Dr. Michael Irwig from George Washington University discusses his published study on persistent sexual side effects from Finasteride (Propecia) in young men aged 21-46.
- A recent study by GW Professor Michael S. Irwig reveals persistent and possibly permanent side effects associated with a common hair loss drug.
March 23, 2011
Men taking medication for hair loss may suffer from prolonged and possibly irreversible sexual dysfunction, according to a recent study by Assistant Professor of Medicine Michael S. Irwig.
The study, recently published in the Journal of Sexual Medicine, reveals that finasteride--an antiandrogen that treats hair loss and is found in popular male pattern baldness drug Propecia--can cause persistent sexual dysfunction, including low sexual desire, erectile dysfunction and problems with orgasms.
While labeling on the medication in the U.S. currently warns about possible reversible sexual side effects, there is no reference to the effects being persistent, says Dr. Irwig, who conducted the study along with Swapna Kolukula of the Greater Baltimore Medical Center. Other countries, including the United Kingdom and Sweden, have documented persistent risks and required medical companies to include them in labeling.
Dr. Irwig first became aware of the problems caused by finasteride several years ago when he encountered several men who reported they had developed sexual dysfunction while taking the medication.
“It’s been very frustrating for a lot of these men because they’ve sought care from medical professionals who have looked at the literature and have not seen a risk of persistent sexual dysfunction,” says Dr. Irwig. “So a lot of these patients have been told to see psychiatrists and psychologists and that it’s all in their head.”
Dr. Irwig then noticed that men had reported sexual dysfunction for months after they stopped taking the medication.
“I came across a website called propeciahelp.com with more than 1,400 registered users—many young healthy men who developed the same sexual side effects from finasteride—and I discovered that nobody had published a series looking at these men—who they are, how long the sexual side effects lasted, what types.”
Dr. Irwig’s study included results from interviews with 71 men aged 21 to 46 years old to assess how long they took finasteride, the type and duration of sexual side effects and their sexual frequency before and after the medication.
Dr. Irwig discovered that 94 percent developed low libido, 92 percent developed erectile dysfunction and decreased arousal, and 69 percent developed problems with orgasm. On average, the men used finasteride for approximately 28 months but experienced persistent sexual side effects for an average of 40 months, from the time they ceased taking the medication to the time of the interview.
Dr. Irwig also found that the average number of sexual episodes per month dropped after finasteride use.
“It turns out that almost all the men had multiple sexual function problems,” says Dr. Irwig. “Before finasteride use, the men experienced average sexual activity of approximately 26 episodes per month, but after use, it came down to approximately eight per month —an almost two-thirds reduction.”
“Twenty percent of patients I interviewed experienced persistent sexual dysfunction for more than five years, which makes me wonder if their persistent sexual dysfunction is permanent,” he adds.
Dr. Irwig says roughly 5 percent of men who take medicine will experience sexual dysfunction, but that “out of that 5 percent, it’s hard to tell how many will experience persistent symptoms.”
“We know that this is a potential problem, but we can’t quantify what the exact risk is. I can’t tell a man if he has a 1-in-100 chance, or a 1-in-1000 chance of developing persistent sexual dysfunction, but it’s pretty clear there’s a relationship here,” he says.
Topical Rogaine can be used as an alternative to Propecia —applied directly on the skin, it does not get absorbed by body and thus does not cause sexual side effects—but Dr. Irwig says Propecia is very effective in treating hair loss and thus is commonly prescribed.
So Dr. Irwig says it is crucial physicians treating male pattern hair loss discuss the possibility of persistent sexual side effects associated with finasteride with their patients.
“I think it’s very important that doctors who are prescribing this medicine talk about potential risks, so men can make an informed decision,” he says.
- ABC News: Pursuit of Better Hairline Costs Some Men Their Sex Lives
The baldness drug finasteride has left some young, otherwise healthy men with persistent impotence, diminished sex drive and depression long after they've stopped taking it, according to emerging medical studies and patient reports, as well as lawsuits filed in the United States and Canada.
... Although the generally rare sexual side effects of finasteride and dutasteride have been mentioned at urology meetings, information about potentially irreversible consequences hasn't yet reached the larger community of prescribing physicians, such as dermatologists and primary care doctors -- or their patients, said researcher Abdulmaged M. Traish, a professor of biochemistry and urology at Boston University School of Medicine.
For an article published in the March issue of the Journal of Sexual Medicine, Traish and a B.U. colleague, along with Dr. Andrew T. Guay of the Center for Sexual Function/Endocrinology at the Lahey Clinic, Northshore, in Peabody, Mass.; a reproductive medicine specialist from Muenster, Germany; and an ob-gyn from Stavanger, Norway; reviewed available scientific studies on the adverse effects of finasteride and dutasteride. Although the overall percentage of study subjects reporting sexual side effects was small, ranging from 5 percent to 23 percent, Traish said side effects never went away for half of them.
"We found out that we're really ignoring the important part, especially those in whom the problem becomes persistent," Traish said in an interview Wednesday. "That's the group that everybody forgot. We have to worry about the consequences for people who are going to suffer -- even after they discontinue the drug -- from continuous loss of libido and potential depression." Other observed effects included reduced ejaculation and smaller volume of semen.
Study Meant to Encourage Open Discussions Between Docs, Patients,
Traish said his paper was meant to encourage doctors to "sit down and discuss this openly, candidly and honestly" with patients, and to encourage patients to consider the possibility, small as it might be, that they could potentially sacrifice a meaningful sexual life "to improve my hairline and look good in the bar while I'm watching football."
He said he gets "a number of e-mails every week from individuals who say 'this is my life story.'"
... Dr. Michael Irwig, an endocrinologist at George Washington University, interviewed 100 healthy men, aged 21 to 46, in the past year who took finasteride for hair loss and reported sexual side effects or depression after they stopped the drug. He tracked down the men, half of whom live overseas, through the Propeciahelp.com Web site, which has been visited by more than 1,700 men with problems following finasteride use.
Irwig said he has seen men "who have actually been suicidal; some who have lost their jobs" because of psychological and physiological fallout after using the medication. "I had one guy in his early 20s fly all the way from Australia, who is that desperate," he said.
Irwig said there was "strong evidence" that finasteride interferes with hormones in the brain, called neurosteroids, which in turn alter levels of important chemicals called neurotransmitters that affect mood and thinking, among other critical functions.
Irwig said he was surprised at the dearth of published material, given that finasteride has been around for 10 years and "there have been guys who have had persistent side effects for 5 and 10 years already."
Although reversible effects have been well-known, he attributed the scant knowledge about persistent effects to their relative absence in medical literature until now. "A guy will go to a doctor and will say, 'I think this medicine has caused ED [erectile dysfunction] that hasn't gone away," he said.
But because the doctor hasn't been exposed to such cases, he or she will tell the patient it's supposed to go away and refer the patient to a psychiatrist.
Study Coming Out This Week Should Make Issue Legitimate, Author Says
"This will finally give evidence that this exists and will make this legitimate and doctors won't blow these patients off," Irwig said. "And now, most importantly in terms of prevention, we can have an informed discussion; men contemplating using this medicine and doctors prescribing it."
- Men Report Sexual Impairment After Using Common Hair Loss Drug
Men who have taken a popular pill for baldness say they've experienced persistent sexual dysfunction for months, or even years, after stopping the drug.
The new study, published in the Journal of Sexual Medicine, found that men who take finasteride, sold under the brand names Propecia and Proscar, may develop an ongoing loss of libido and orgasm, even after they go off the medication.
In some cases, they could have other lasting sexual side effects, including premature ejaculation and erectile dysfunction, according to lead researcher Dr. Michael Irwig of George Washington University's medical school.
"It's obviously having some effect on the brain," Irwig told AOL Health. "It's messing up different hormonal pathways. Some of these pathways are important for things like libido and sexual function."
Finasteride, the most common hair-loss pill, has previously been linked to "reversible" sexual impairment, as noted on the drug's label, said Irwig. But "this is the first series to find that symptoms persisted for at least three months despite stopping finasteride," he added.
"Three months was the minimum, but some of these guys had sexual symptoms for years, some ... for five to 10 years after," he told AOL Health. "These were young guys with no medical problems, no psychiatric problems, who happened to develop these side effects."
Irwig and his team interviewed 71 men aged 21 to 46 who had taken Propecia or Proscar and reported new sexual side effects after they started the drugs. None of the participants had a history of sexual dysfunction or other conditions that might have contributed, Irwig said -- and some had only been on finasteride for a few days.
Ninety-four percent said they'd experienced low sexual desire, 92 percent reported a dip in sexual arousal and 69 percent had trouble with orgasm, according to the findings. Another 92 percent said they developed erectile dysfunction after taking finasteride.
On average, participants had been on the baldness drug for 28 months and had chronic sexual problems for an average of 40 months, the research showed.
But 10 percent of those studied had used finasteride for less than a month, Irwig told AOL Health.
"It's scary," he said. "For the lack of orgasm and libido, there is no treatment."
Other reported adverse side effects of finasteride are depression, suicidal thoughts and anxiety. Merck is currently fighting a number of lawsuits involving the drug, including one in Canada and another in Connecticut.
The company does not warn of possible psychological or persistent sexual problems in information about finasteride on its website, nor does it mention those symptoms on its U.S. labeling. Irwig said the drug does carry warning labels in the U.K. and Sweden about ongoing sexual impairment.
"Be aware that this is a potential sexual side effect," he cautioned. "If somebody chooses to take this medicine, there is that risk. They have to make the decision that it's a risk they're willing to take."
March 2011 - STUDY PUBLISHED: Adverse Side Effects of 5α-Reductase Inhibitors Therapy: Persistent Diminished Libido and Erectile Dysfunction and Depression in a Subset of Patients
- WebMD - Study: Sexual Side Effects of Hair Loss Drugs Persist
... But the review says less attention has been paid to uncommon but potentially devastating side effects of these medications.
Those side effects can include anxiety, depression, loss of sex drive, difficulty getting or maintaining and erection, gynecomastia (growth of male breast tissue), and reduced semen production, which may affect fertility.
What’s worse is that for some, these side effects persist, even when they stop taking the medication, according to the review.
“We don’t really understand why, but the symptoms remain persistent or irreversible and even if they get off the drug,” says study researcher Abdulmaged M. Traish, PhD, a professor of biochemistry at the Boston University School of Medicine. “They no longer regain what they had before. Biologically, something gets shut off and gets shut off once and for all.”
Traish thinks that may be because nerves that are maintained by dihydrotestosterone become permanently degraded and can’t be repaired even after men come off the medication.
- USA TODAY: Sexual Side Effects From Propecia, Avodart May Be Irreversible - US News and World Report
Use of dutasteride (Avodart) and finasteride (Proscar and Propecia) were linked to erectile dysfunction, depression and loss of libido in a review of existing studies. In a small percentage of cases, symptoms persisted even after the medication was stopped.
For those men, "it's a life sentence," said lead researcher Abdulmaged M. Traish, a professor of biochemistry and urology at Boston University School of Medicine. "No sex. No desire. Potential depression," Traish added. Almost everyone who takes these drugs experiences some of these side effects, Traish said. "But, some experience it more drastically than others," he added.
... " We need androgen for erectile function, libido and ejaculation, and for just feeling good," Traish said. Noting that increasing numbers of patients report ongoing sexual problems after they stop taking the drugs, Traish said, "That's where the light should be shined."
"I am not worried about those who stop taking the drug and get their life back, [my concern is] about those who stop taking the drug, but they don't get their life back," Traish said.
- Popular Drugs For Common Male Health Problems Can Affect Their Sexual Health
... Dr. Irwin Goldstein, editor-in-chief of The Journal of Sexual Medicine, has seen and evaluated numerous such patients. He further explained the importance of this study.
“Young men are being prescribed 5 alpha reductase inhibitors as hair loss treatments that may negatively impact their sexual life, possibly for a prolonged time after stopping the medication.
Older men with symptoms of lower urinary tract symptoms or fearful of prostate cancer, now have to deal with new onset sexual and mental health problems. The growing use of 5 alpha reductase inhibitors is causing concerns.
Clearly more research is needed to better understand the basis for these drug-associated side effects but it is evident that 5 alpha reductase inhibitors prevent the synthesis of very critical central nervous system neurosteroids and lower a very important sex steroid hormone, dihydrotestosterone."
December 2010 -- MERCK adds "DEPRESSION" as possible Propecia side effect
It's official -- Merck USA has added "DEPRESSION" to it's list of Finasteride side effects reported in post-marketing use:
Pg. 2 - What are the possible side effects of PROPECIA?
December 2010 -- BBC Radio 1 Report: Baldness drug Propecia 'risking men's sexual health'
Article: Baldness drug Propecia 'risking men's sexual health'
By Simon Mundie
03:21 GMT, Tuesday, 21 December 2010
"Young men could be risking their sexual health by taking the world's best selling anti-baldness drug, claim some doctors. They say finasteride - sold in this country as Propecia - can cause serious side effects and that the drug's labelling is inadequate.
Male pattern baldness affects six and a half million people in the UK. It's estimated that a quarter of men will start showing signs in their twenties. James, 26, from Edinburgh was one of them.
"I noticed hair loss, hair coming out in the shower and on the pillow, and I freaked out basically. I went onto the internet and researched it. I found out there was a drug called Propecia, and soon enough I started buying that and it worked a treat."
The prescription pill is extremely effective at stopping hair loss and in clinical trials nine out of 10 men didn't lose any more hair over a five year period. Drugs' company Merck, which manufactures Propecia, claims on its website that less than 2% of men could suffer sexual side effects.
It mentions things like difficulty achieving an erection, but says the problems will go away for men who stop taking the drug. For James, that was when the problems started. He'd stopped taking the drug after noticing he had less interest in sex - but he says things soon got worse.
"After about three weeks all hell broke loose. I more or less became completely impotent." He went to see a specialist a few months later. "He put me on testosterone therapy, which is a lifelong commitment", says James. "Unfortunately that didn't work either. I went back to him six months later and he offered me the chance of a penile implant."
There are doctors in Ireland and the US who claim cases like James's aren't unusual and that the drug's labelling is inadequate.
Merck say they continually monitor its safety and have recently changed the labelling after reports of sexual side effects continuing after people had stopped taking the drug. They also claim those cases are extremely rare and could be caused by something other than Propecia itself.
But James is convinced it was his decision to take the drug that caused his problem.
"Every day I wish could turn back the clock. It did work well for my hair, but the cost is ridiculous - losing my sex-life. It's happening to lots and lots of men- and it's about time people woke up to it.""
October 2010 -- Dr. Andrew Rynne Warns Against Finasteride Use In Young Men
Male Pattern Baldness and Propecia.
"I want to shout this from the rooftops. However, I will shout it into cyberspace instead.
I want the ear of every young man on this planet who may be experiencing testosterone driven male pattern balding. Please listen to me. Do NOT under any circumstances even for one minute consider taking the testosterone-suppressing drug Proscar or Propecia or Finasteride to give it its chemical name for male pattern balding.
Here’s what the manufacturers Merck say on their Patient’s Product Information leaflet about Propecia: “In clinical studies for Propecia, a small number of men experienced certain sexual side effects, such as less desire for sex, difficulty in achieving an erection, decrease in the amount semen produced. Each of these side effects occurred in less than 2% of men and went away in men who stopped taking Propecia because of them.”
What jumps out at you here is that figure 2%. However, even if you accept this figure as true, and personally I do not accept it, but even if you do, to the uninitiated it might seem like a low figure. But for 2% of men on Proscar to experience serious side effects like erectile dysfunction, loss of libido and reduced volume of semen this is actually a very high and significant figure. Remember you are dealing here with a naturally occurring normal male phenomenon called ‘Male Pattern Baldness’. This is not an illness or a disease. This is a healthy normal occurrence. If in an attempt to “cure” it, you are getting a 2% rate of serious side effects, then that quite frankly is unacceptable.
But here is the real lie that Merck is giving you in its Patient’s Leaflet. Do you see that bit there about “went away in men who stopped taking Propecia – ” That is simply not true and Merck know full well that it is not true. They know it is not true because I and hundreds of other doctors and thousands of patients have told them that these side effects do not always go away when you stop taking Propecia. We continue to be ignored of course. Merck in a multi-billion multinational company.
In some cases men who have taken Proscar, even for a few months, have unwittingly condemned themselves to a lifetime of Sexual Anhedonia, the most horrible and cruel or all sexual dysfunctions. I have spoken to several young men in my clinic in Kildare who continue to suffer from sexual anaesthesia and for whom all sexual pleasure and feelings have been obliterated for all time. I have felt their suffering and shared their devastation.
If you would like to learn more about this subject then visit them on http://www.propeciahelp.com. Please spread the word around. Taking Propecia for balding can have utterly disastrous consequences. If you have suffered in any way as a consequence of having used Propecia or Proscar them please use the comment box below to share your story with us. We would love to hear from you."
October 2010 - Update from Dr. Jacobs on persistent Finasteride side effects -- epigenetics and androgen receptors
Dr. Alan Jacobs has written a new blog post, outlining some possible areas of investigation for persistent Finasteride side effects: epigenetics and androgen receptors.
"The persistence of male sexual side effects (hypogonadism) after discontinuation of finasteride is a serious problem for a significant subset of men who use the drug.
I had previously written about whether the propensity of finasteride to cause lasting hypogonadism could be due to the development of partial androgen resistance and whether this relates to the number of CAG repeats in exon 1 of their androgen receptor genes.
Recently, a patient of mine brought to my attention a research paper from Csoka, et al.(J Sex Med 2008;5:227-233) titled "Persistent Sexual Dysfunction after Discontinuation of Selective Serotonin Reuptake Inhibitors". They added 3 well-characterized case reports to the half dozen or so that were already in the literature and cited studies probing underlying mechanisms for the problem.
Their fourth proposed mechanism relates to a growing field that has caught my attention in a big way, the field of epigenetics. They note that antidepressants can cause complex changes in the expression of genes. They cite animal research that has linked SSRI treatment during youth to permanantly decreased sexual behavior that persits into adulthood and that has explored underlying mechanisms for this including brain epigenetic changes at the molecular level.
Epigenetics is a field that concerns the complex web of proteins that surround our DNA. These proteins include histones, which help package and unpackage our genes to either turn on or turn off their function. "Acetylation" and "methylation" are chemical reactions that alter the histone's function, which in turn alters the expression of our genes. Within this emerging field may lie a new mechanism by which a drug can cause persistent changes in gene expression that can influence sexual behavior.
This brings up the idea that there is a common epigenetic mechanism that may apply generally to medications that cause persistent sexual dysfunction. It may be the case with finasteride that a common epigenetic effect interacts with a less common variant in the androgen receptor gene CAG repeat profile to cause its syndrome of crippling persistent post-finasteride hypogonadism.
Human research in this area has yet to be done, but holds promise for new therapies to treat this troublesome side effect of finasteride and other widely used medications.
May 2010 - Doctor confirms persistent Finasteride side effects, Post-Finasteride Syndrome; clinical evaluation & potential treatments.
Dr. Alan Jacobs MD (neuroendocrinologist) confirms persistent Finasteride side effects, clinical evaluation of the Post-Finasteride Syndrome, some treatment options and possible causes.
- A Neuroendocrine Approach To Finasteride Side Effects In Men
- The Plot Thickens, Along With The Hair, When You Mess With Dihydrotestosterone
- A Proposed Mechanism For Prolonged Sexual Side Effects From Finasteride
- I have recently seen an increasing number of men who have developed significant degrees of clinical hypogonadism - low sex drive, erectile dysfunction, reduced sexual sensations and listlessness, fatigue and/or "brain fog" - while either taking finasteride or after stopping the medication, even long after stopping it.
- A considerable number of men have intolerable and sometimes persistent side effects from the medicine. The occurrence of these symptoms in the setting of being on, or even after stopping, the medicine presents a compelling neuroendocrine problem.
- It is reasonable to assume that not all men suffer from the exact same cause
- The investigation of this problem begins with measuring blood levels of the testicular hormone testosterone, DHT and luteinizing hormone (LH) and follicle stimulating hormone (FSH)
- If testosterone is low and LH and FSH are low or even normal, then the problem is "upstairs" either in the pituitary gland or in higher brain centers that control hormones
- If high normal levels of testosterone, combined with low estrogen levels, does not relieve the hypogonadal symptoms, then the possibility that the man has some resistance to testosterone must be considered
- Other brain hormones can be effected by finasteride. These are called neurosteroids and their decline can bring anxiety and depression. These neurosteroids cannot yet be measured commercially with blood tests
- A systematic neuroendocrine approach to this problem should shed light on the cause in a majority of cases and bring relief