The Blog

By: John Peige, Baltimore Courts Examiner

“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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