“The U.S. Food and Drug Administration has confirmed it is conducting a new safety review of the hair growth drug Propecia. In response to written questions submitted by the Examiner, FDA spokesperson Sandy Walsh wrote in an email that, “The focus of the current review is the persistence of severe male sexual dysfunction after discontinuation of Propecia’s use. This review was prompted by routine drug safety surveillance.”

FDA’s safety investigation comes as a growing number of men say Propecia’s severe side effects have caused them to suffer persistent and permanent sexual dysfunction. While several European countries have required Propecia’s maker, drug-giant Merck & Co., to issue warnings regarding the drug’s irreversible side effects, this marks the first time the FDA has acknowledged it is reviewing the drug’s safety here.

Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. When prescribed in 5mg doses to treat enlarged prostate it is sold under the brand name Proscar. The FDA approved Propecia in 1997 and reports that Merck’s annual Propecia sales are over $400 million
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In her email to the Examiner, Ms. Walsh wrote that, “Routine safety surveillance includes a number of things, like regular monitoring of adverse event (MedWatch) reports (AERS), reviewing scientific literature and looking at data from post-market clinical trials.”

Ms. Walsh also noted, “Our AERS web site, FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. Potential signals of serious risks are normally based upon groups of AERS reports, although a single AERS report could lead to further evaluation of a potential safety issue.”

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“As controversy swirls over the safety of Propecia, the U.S. Food and Drug Administration continues its silence on the hair-growth drug’s safety.

FDA’s inaction comes despite the drug’s serious side effects being well-documented in this country and Europe.

The FDA’s counterparts in Europe were the first to require Propecia’s maker to include stronger side effect warnings in the drug’s packaging there. In 2006, the Swedish Medical Products Agency began investigating reports of persistent sexual dysfunction side effects which continue in men despite discontinuing finasteride, Propecia’s active ingredient. The drug is manufactured by drug giant Merck.

In 2008, Merck changed the label in Sweden to include the following warning: “In addition, the following have been reported in post-marketing use: persistence of erectile dysfunction after discontinuation of treatment.”

In 2009, the Swedish Medical Products Agency concluded that Propecia could lead to permanent erectile dysfunction. Merck then changed the product label in other European countries to include a warning of permanent erectile dysfunction as an adverse reaction.
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In the United Kingdom, Merck included the following warning: “In addition, the following have been reported in post-marketing use; persistence of erectile dysfunction after discontinuation of treatment with Propecia; male breast cancer.”

In Italy, Merck revised the label in March 2010 to include a warning of persistent erectile dysfunction after discontinuation of treatment.

Yet in this country, the FDA has not issued any warning or alert regarding the persistence of severe male sexual dysfunction after discontinuation of Propecia’s use. The agency’s inaction comes despite two separate studies published last year in The Journal of Sexual Medicine by researchers from the George Washington University and Boston University schools of medicine that reported Propecia’s side effects caused persistant and permanent male sexual dysfunction.”

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“The hair growth drug Propecia has come under increasing criticism from doctors and consumers because of devastating side effects that include persistent and permanent male sexual dysfunction, yet the U.S. Food and Drug Administration remains silent on the drug’s safety.

The FDA did issue a warning last year on Propecia’s link to high-grade prostate cancer but has not issued any new warnings or guidance on the permanence of the drug’s sexual side effects — despite a flurry of lawsuits and the growing number of claims by men who say the drug has ruined their lives.

Drug giant Merck, maker of Propecia, has pulled all information on the drug from its official website (www.propecia.com) in the wake of intensifying controversy fueled by former Propecia users.

“I took the drug for nearly 15 months and after stopping have developed extreme penile and testicular shrinkage, loss of libido, genital pain, ED, depression, muscle waste, weight gain, decreased cognitive ability, inability to sleep with medications among other side effects,“ says Steve Rossello, one of the first men to file a lawsuit against drug giant Merck & Co., Propecia’s maker.

“Obviously this has not only ruined my sexuality but my entire life. I know of other sufferers who have lost their jobs, were divorced by their spouse and some have even committed suicide,” says Rossello.

Rossello’s Propecia experience was consistent with 71 other men who were included in a ground-breaking research study published last year in the Journal of Sexual Medicine by George Washington University School of Medicine Assistant Professor Michael S. Irwig, M.D., which was one of the first to report on the drug’s dreadful side effects.

According to the FDA, Merck’s annual Propecia sales are well over $400 million.

In the U.S., the company promotes the use of Propecia for treatment of male pattern hair loss as a safe treatment with little risk. In its product labeling, Merck says side a limited number of users may experience side effects that include sexual dysfunction like decreased libido and erectile dysfunction — but that these side effects resolve after discontinued use of the drug.

In Europe, however, Propecia carries a much stronger warning. “

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“An unidentified man in Colorado has filed suit against the maker of Propecia, claiming the male baldness drug caused him to suffer erectile dysfunction and other sexual problems. The claim, brought in U.S. District Court for the District of Colorado, is just the latest Propecia lawsuit filed against Merck & Co. by men who say that the drug caused sexual issues.

Propecia (known generically as finasteride 1 mg) is part of a class of drugs called 5-alpha reductase inhibitors, or 5-ARIs. Other drugs in this class including Merck’s Proscar (finasteride 5 mg), and GlaxoSmithKline Avodart (dutasteride) and Jalyn (dutasteride and tamsulosin) are manufactured by GlaxoSmithKline. While Propecia is used to treat male pattern baldness, other 5 ARIs are used to treat enlarged prostate. According to the U.S. Food & Drug Administration (FDA), almost 5 million men were prescribed one of these medications between 2002 and 2009.

Propecia and these other drugs work by preventing the conversion of androgen testosterone to DHT, a hormone critical to male sexual performance. Merck’s label for Propecia warns that side effects may include sexual dysfunction but says the side effects “resolve after discontinued use of the drug. While the Propecia label in Europe was updated in 2008 to warn of “persistent” sexual side effects, no such update has occurred in the U.S.

In March, a group of researchers at Boston University published a study finding that in a small number of cases, erectile dysfunction linked to 5-ARIs may continue after the drugs have been discontinued. The study, which involved a review of available medical literature, found that 8 percent of men taking 5-ARIs reported erectile dysfunction and 4.2 percent reported reduced libido. In the placebo group, only 4 percent reported erectile dysfunction, while only 1.8 percent reported reduced libido. Other men taking the drugs reported reduced ejaculation and semen volume and depression. In some cases, men experienced problems after taking the drugs.”

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“Thank you for your Propecia pieces. I’m 50 and started the med when I was 37. It’s destroyed my life.”   D.W. — Los Angeles

After reading The Examiner’s recently published articles on the devastating side effects of the hair growth drug Propecia, a reader sent the above email. He’s not alone: As word gets out, many more men are now coming forward to say they are also Propecia’s unsuspecting victims.

Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. (When finasteride is prescribed in 5mg doses to treat enlarged prostate – also known as benign prostatic hyperplasia or BPH — it is sold under the brand name Proscar). Drug giant Merck & Co. manufactures Propecia which is sold worldwide.

Doctors who know about Propecia’s hair growth properties have no idea about its serious sexual side effects. “Many of my friends take Propecia and I had no idea it had these side effects … and I stay on top of the latest medical news,” says Dr. Bashir A. Zakria, Assistant Professor, Division of Sports Medicine at Baltimore’s Johns Hopkins Medical Institutes.

Propecia’s sexual side effects include erectile dysfunction, impotence, greatly reduced libido, testicular pain, problems with orgasms and gynecomastia – an over-development of the male breast frequently associated with social and emotional trauma in men.

Dr. Michael S. Irwig, Assistant Professor of Medicine at George Washington University’s School of Medicine conducted the ground-breaking research published last year in the Journal of Sexual Medicine that was one of the first studies to report on Propecia’s dreadful side effects. “Seventy-one men between the ages of 21 and 46 participated in the research and about half were from outside the United States. I have seen patients from as far away as Australia and England,” says Dr. Irwig.

He found that 94 percent developed low libido, 92 percent developed erectile dysfunction and decreased arousal, and 69 percent developed problems with orgasm.

“It turns out that almost all had multiple sexual function problems. Men reported average all inclusive sexual activity of approximately 26 episodes per month before taking Propecia, but there was an almost two-thirds reduction in sexual activity after using the drug.”

Dr. Irwig believes this is just the tip of the iceberg.

While the FDA remains quiet on the subject, word is slowly getting out as more media outlets cover the emerging story.

Just over a year ago, CBS Money Watch ran a story that tied Propecia to persistent sexual side effects that were not fully disclosed on the drug’s labeling.

The January 13, 2011 article reported that, “Merck (MRK) is experiencing some rough PR issues on its hair-loss drug Propecia following a study that suggests up to 15 percent of men taking the drug might experience some form of sexual dysfunction. For years, the warning label on Propecia has said that only 2 percent of men might experience erectile dysfunction while using the drug, and if users stop taking the pills everything returns to normal.”

The story by correspondent Jim Edwards went on to report that: “But a new study, in the Journal of Sexual Medicine, suggests the rate of dysfunction is a lot higher and that in some cases men are permanently hobbled by erectile dysfunction or loss of libido even after stopping the drug. The study dovetails with a recent BBC report on one 26-year-old man who claims the drug ruined his life.

The Money Watch article went on to reveal that, “A quick search of hair-loss comment boards shows that plenty of men have had the same experience: They grew hair but lost their sex lives.”

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“Propecia® (finasteride) is a prescription medication that is used for hair loss treatment in men with certain types of male pattern baldness. As with all medicines, side effects are possible, and some can affect a person’s sexual well-being. In the case of Propecia, sexual side effects that have been reported include:

Decreased sex drive (libido).

Impotence. Impotence is usually defined as a total inability to achieve erection, an inconsistent ability to do so, or a tendency to sustain only brief erections. Ultimately, impotence is the repeated inability to get or keep an erection firm enough for sexual intercourse. Impotence is also known as erectile dysfunction (or ED for short).

Decreased ejaculate amount.

How Common Are Sexual Side Effects With Propecia?
Before medicines are approved, they must go through several clinical studies, where thousands of people are given a particular medicine and compared to a group of people not given the medicine. In these studies, side effects are always documented. This way, it is possible to see what side effects occur, how often they appear, and how they compare to the group not taking the medicine. Side effects are then usually separated into those that occur in more than 1 percent of people (common) and those that occur in less than 1 percent of people (rare).”

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“In recent weeks, lawsuits have been filed in the US and Canada by men who claim their sexual functioning dramatically decreased after taking the Merck Propecia pill that is used to treat hair loss (read one here). Now, a study has reported for the first time that the medicine does, indeed, cause persistent sexual dysfunction, contradicting information disseminated by the drugmaker.

Here is the bottom line: the researchers interviewed 71 otherwise healthy men between the ages of 21 and 46 years old. These men reported the onset of sexual side effects associated with the use of the drug and in which symptoms continued for at least three months, despite having discontinued treatment. [The med, by the way, is called finasteride and Merck markets a higher dose called Proscar to treat enlarged prostates.]

To be specific, 94 percent developed low libido, 92 percent developed erectile dysfunction, 92 percent developed decreased sexual arousal and 69 percent developed problems with having an orgasm. The mean number of sexual episodes per month dropped from 25.8 to 8.8, and the total sexual dysfunction score on a standardized scale increased before and after using Propecia. At the time the interviews were conducted, the mean duration of the persistent sexual side effects was 40 months, with 20 percent of the participants reporting problems lasting more than six years.

By contrast, the US prescrbing information on the Propecia labels says that most men who experienced decreased libido, ejaculation disorder and erectile dysfunction were able to bounce back. “Resolution occurred in men who discontinued therapy with Propecia due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to ≤0.3 percent by the fifth year of treatment” (see page 9).

“This is the first trial to show this medication can cause persistent sexual side effects,” says Michael Irwig of the Center for Andrology and Division of Endocrinology at The George Washington University and a co-author of the study, which was published in the Journal of Sexual Medicine (see the abstract). “And the risk needs to be known when men are contemplating taking the medication and doctors are prescribing the medication.”

In other countries, the labeling is different. The UK’s Medicines and Healthcare Products Regulatory Agency and the Swedish Medical Products Agency have both updated their patient info leaflets to include a statement that “persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use.”

“The looming question for all the subjects is whether their sexual function will ever recover. Many of the study participants have developed anxiety and depression as a consequence of their sexual dysfunction and all reported a significantly decreased quality of life, especially with dating and intimacy,” the authors write.

They acknowledged, however, several limitations, including selection bias in which those subjects experiencing more severe side effects, or those for whom sexuality is a more significant aspect of their life, would be more likely to participate in a study looking at sexual parameters. Another limitation is recall bias. And they note the study does not prove that Propecia caused persistent sexual side effects.”

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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. Propecia is manufactured by drug giant Merck & Co., one of the world’s largest pharmaceutical companies.

Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. (When finasteride is prescribed in 5mg doses to treat enlarged prostate – also known as benign prostatic hyperplasia or BPH — it is sold under the brand name Proscar.)

Propecia’s sexual side effects include erectile dysfunction, impotence, greatly reduced libido, testicular pain, problems with orgasms and gynecomastia – an over-development of the male breast frequently associated with social and emotional trauma in men.

“As my study shows, there are very real sexual health issues that are affecting a population of previously healthy men ranging in age from 21 to 46 years old who took Propecia,” says George Washington University Professor Michael S. Irwig, M.D., whose ground-breaking research published last year in the Journal of Sexual Medicine was one of the first studies to report on Propecia’s dreadful side effects.

Dr. Irwig serves as the Director for the University’s Center for Andrology and is an Assistant Professor of Medicine at GW’s School of Medicine. He received his medical degree from New York’s Cornell University, served an internal medicine residency at the University of Virginia and practiced endocrinologyat Baltimore’s Sinai Hospital before taking his current position. Late last week, he sat down for an exclusive interview with The Examiner at his Washington, DC office.

“I first became interested in this area several years ago when several men reported they had developed persistent sexual dysfunction while taking the medication.” As the number of men encountering side effects increased, Dr. Irwig decided to initiate his study which was non-funded.

“Seventy-one men participated in the research and about half were from outside the United States. I have seen patients from as far away as Australia and England,” says Dr. Irwig. He found that 94 percent developed low libido, 92 percent developed erectile dysfunction and decreased arousal, and 69 percent developed problems with orgasm.

“It turns out that almost all had multiple sexual function problems. Men reported average all inclusive sexual activity of approximately 26 episodes per month before taking Propecia, but there was an almost two-thirds reduction in sexual activity after using the drug.”

While the FDA issued a new warning regarding Propecia’s link to high-grade prostate cancer — the most aggressive and deadly form of the disease — the agency has been ineffective in getting the word out to prescribing doctors regarding the growing evidence of Propecia’s substantial side effects. The FDA has not issued any warnings or recalls regarding those sexually destructive symptoms.

“It’s been very frustrating for a lot of these men because they’ve sought care from medical professionals who are unaware of the risk of persistent and serious sexual dysfunction since it was not originally suggested in the literature,” Dr. Irwig said.”

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“LOS ANGELES — A man who took the male pattern baldness drug Propecia for four years claims it gave him “severe sexual dysfunction and cognitive impairment.”

Jason McCord sued Merck & Co. in Federal Court.

Merck has been sued at least 15 times in the past two years for similar claims, according to the Courthouse News database.

McCord says he was 36 when he was prescribed Propecia, in 2006, and he took it for four years. He says the trade-off wasn’t worth it.

“Male pattern hair loss affects 30 percent of men by the age of 30 years and 50 percent of men by the age of 50 years. Men who suffer from hair loss may be perceived as older and less physically and socially attractive,” according to the complaint.

“Male pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a hormone called dihydrotestosterone (‘DHT’).

“DHT is a substance in the body that can shrink hair follicles until a person no longer has hair on top of his head.

“Finasteride is a 5-alpha reductase inhibitor that decreases the conversion of testosterone to DHT, therefore, preventing hair loss.

“Propecia, or finasteride, may produce undesirable side effects to patients who use the prescription drug, including but not limited to, sexual dysfunction and cognitive impairment.

“The rates of the sexual dysfunction as a result of finasteride are reported to be as high as 39 percent in published clinical studies. In addition, it has been reported in 2003 that only 50 percent of patients experience resolution of their sexual function adverse events after discontinuation of finasteride.”

The U.S. FDA approved Propecia for hair loss in 1997 and more than one million people have taken it by prescription, McCord says.”

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“Merck & Co. has agreed that all Propecia lawsuits filed in federal district courts throughout the United States by men who experienced sexual problems after using their hair-loss drug should be consolidated before one judge for pretrial proceedings.

Merck Prefers New Jersey

Merck has suggested that the U.S. Judicial Panel on Multidistrict Litigation should transfer all cases to the U.S. District Court for the District of New Jersey, where 41 of the 53 lawsuits over Propecia have already been filed.

Some plaintiffs proposed that the Propecia MDL be centralized in the U.S. District Court for the Eastern District of New York, or, in the alternative, in the U.S. District Court for the Western District of Washington.

Merck’s attorneys claim that moving the cases to the Eastern District of New York, or the Western District of Washington, would be inefficient because the courts lack familiarity with issues already addressed in a number of the cases.

Judicial Panel on Multidistrict Litigation

The U.S. Judicial Panel on Multidistrict Litigation is expected to hear arguments on the consolidation of the lawsuits over Propecia at a hearing scheduled for March 29, 2012 in San Diego, California.

It appears that all parties agree that centralizing the Propecia cases as part of an MDL, or multidistrict litigation, would serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulings. However, the MDL panel will have to determine what is the most appropriate transfer jurisdiction.”

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