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Tough medicine: Reporting Propecia’s side effects to the FDA

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Posted On 04.06.12 by in Blog

As Einstein discovered, every action has an equal and opposite reaction. But you don’t need to be a mathematical genius to know when things don’t add up — sometimes it takes individual action to trigger a reaction for the greater good.
Case in point: Many men say they have suffered persistent and permanent sexual side effects after taking the hair growth drug Propecia. The U.S. Food and Drug Administration has remained silent on their claims, despite action taken by the agency’s European counterparts warning of the irreversibility of Propecia’s side effects.
“I took the drug for nearly 15 months and after stopping have developed extreme penile and testicular shrinkage, loss of libido, genital pain, erectile dysfunction, 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,” says Rossello, who has shared his experience publicly in the hopes that the FDA will take appropriate action so that others won‘t needlessly suffer a similar fate.
“Just as word of mouth is the most effective form of advertising, hearing directly from a person affected by a drug’s side effects should carry a lot of weight with the FDA,” says Baltimore-based attorney Alan Horwitz (www..com). “While we are currently working through the legal system on the behalf of many Propecia clients, it is a slow process.”
Horwitz says his clients tell him that they never want what has happened to them to happen to another person. “That’s why I advise them that besides seeking recovery through legal means, they can also use the FDA’s MedWatch reporting system, since it is the fastest way to make an impact on the FDA. My thought is that as the FDA becomes more aware of the true scope of the problem they will issue a new alert warning others of Propecia’s permanent side effects.” Those affected can click on (www.fda.gov/Safety/MedWatch) or call the FDA at 1-800-FDA-1088 to report by phone.
Dr. Michael Irwig, Assistant Professor of Medicine at the George Washington University School of Medicine agrees with Horwitz: “The medical community is skeptical of any claimed side effect unless it can be proven by blood work or some other medical test. The more men who notify the FDA directly about their negative experience with Propecia, the more attention it should create within the agency, and hopefully, the FDA will thoroughly investigate.”
According to the online newsletter propecialawsuit2012.com,“Even though many men have experienced similar problems, the effect on each man’s life has been very personal and goes beyond any short term emotional distress and affecting their relationships and in some cases causing depression and other emotional problems. The increasing number of men reporting permanent erectile dysfunction after using Propecia means lawyers representing them will look to multidistrict litigation (MDL) to more efficiently manage an even larger number of men expected to come forward making individual claims rather than forming a Propecia class action.”
BreakingLawsuitNews.com reports that the U.S. Judicial Panel on Multidistrict Litigation will hear oral arguments on March 29 in San Diego regarding the centralization of all Propecia lawsuits. More than 50 lawsuits have been filed in federal court stating that Merck failed to warn physicians and patients about the long-term side effects of Propecia. Lawyers are now handling Propecia lawsuit, claims and settlements in 49 states and the District of Columbia.
As GW University’s Dr. Irwig stated when first interviewed by The Examiner on his ground-breaking research study on Propecia‘s persistent and permanent side effects, “As word spreads, I really think this is just the tip of the iceberg.” So far, his Propecia prophecy seems to be turning into a chilling reality.

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