FDA remains silent as debate intensifies over Propecia’s safety

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, over five million men were prescribed the medication between 2002 and 2009. No doubt, many more have joined that number since then — yet none have been warned of the increased risk that could result in a loss-of-manhood life sentence.

Merck’s annual Propecia sales are 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.

That’s because in 2006, the Swedish Medical Products Agency began investigating reports of persistent sexual dysfunction side effects which continue in men despite discontinuing finasteride, which is Propecia’s active ingredient. 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 changed the product label in other European countries to include a warning of permanent erectile dysfunction as an adverse reaction.

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 the U.S., Merck still does not include a warning regarding the persistence of sexual dysfunction after discontinuation of Propecia’s use.

“The FDA needs to step in and take immediate action in light of the preponderance of evidence that Propecia can permanently destroy a man‘s sexual being,” says Alan Horwitz of Ingerman & Horwitz LLP, a personal injury law firm. (www..com)

In response to the Examiner’s previous articles on the dangers of Propecia, one reader sent the following email:

“I am just writing to thank you for helping to bring more attention to the Propecia (finasteride) issue concerning all the side-effects myself and thousands of other men are facing. I have been through so much hell from this drug. It has ruined far more then my sexual function and it may end up costing me my career due to the severe depression. So many people are in the dark about this drug including doctors, 90% of the specialists I went to regarding it had no idea about the side effects, some flat out denied they were possible. One doctor even went as far to tell me I may have a ‘body image disorder’.”

Says Horwitz: “Just when word was finally getting out in this country about Propecia’s life-damaging side effects, Merck pulled the plug on its consumers. Millions of Propecia users are now left adrift in cyberspace to fend for themselves. One hopes the FDA will now take the appropriate action to finally address Propecia’s real dangers ..

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