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Urgency increases for FDA to provide guidance on Propecia’s safety

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Posted On 07.05.11 by in Blog

As controversey 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.

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.

Millions of men who have been prescribed Propecia have no idea that they may be at risk. Perhaps even worse, many doctors are still prescribing Propecia unaware of the drug’s recently disclosed side effects since they were not included in the drug’s original literature.

There is no known cure for men who have had their sexual function permanetly harmed by Propecia. What is known is that unlike the vast majority of drugs whose side effects cease when you stop taking them, Propecia is different.

Dr. Michael Irwig, lead researcher for the GW University School of Medicine research study, explains that “finasteride 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.”

Merck’s response to the intensifying debate over the drug’s safety has been to pull all content from its official Propecia website … making it unavailable to the public. (www.propecia.com)

While Merck offered no reason for the unusual move, it comes as over 70 lawsuits have already been filed on behalf of men who say they are suffering from Propecia’s previously undisclosed side effects.

“Each day, I hear from more and more men who tell me taking Propecia has shattered their lives,” says Alan Horwitz of the Ingerman & Horwitz LLP law firm (www.ihlaw.com). “In fact, we’ve received so many inquiries questioning Propecia’s safety since Merck pulled it’s content off the Internet, we‘ve posted Propecia information on our own website that highlights the drug’s severe side effects.” The drug’s side effects include erectile dysfunction, impotence, greatly reduced libido, testicular pain, problems with orgasms and Gynecomastia – an over-development of the male breast.

The FDA approved Propecia in 1997 despite any indepth study of the drug’s long-term side effects, which was of concern to at least one member on the drug’s approval committee. At that time, FDA dermatologic drug chief Dr. Michael Weintraub said his main concern was whether it was safe for young men to take a pill for many years … especially one that affects hormones … merely to fight hair loss.

Doubts on the drug’s safety were also raised from outside the FDA. In 2000, Dr. Sherman Frankel, Professor of Physics at the University of Pennsylvania, petitioned the FDA to reconsider Propecia’s approval. Dr. Frankel asserts that Propecia contains 20 times the amount of finasteride required to promote hair growth. He warned of the potential for serious side effects at the higher dose. The FDA rejected Frankel‘s request.

According to the FDA, over five million prescriptions were filled for the drug between 2002 and 2009 alone. Over a million more scripts have been written since then. The agency reports that Merck’s annual Propecia sales are well over $400 million.

Says Propecia attorney Horwitz: “The FDA needs to take immediate action to protect the well-being of an unsuspecting public and also alert members of the medical community about Propecia’s real dangers.”

GW’s Irwig agrees, saying, “I am in favor of anything that helps spread the word on Propecia’s devastating side effects and will be glad to present my findings to doctors at any hospital or medical institution in the world. I really think this is just the tip of the iceberg.”

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