FDA Gets Pressure to Provide Guidance on Safety of Propecia

The team of drug injury attorneys at Arnold & Itkin is well aware of the dangers surrounding the hair loss drug Propecia, but it appears that the Food and Drug Administration (FDA) still isn't. As we have previously reported, European countries have already altered the literature accompanying Propecia prescriptions to reflect the drug's potentially serious and long-term side effects, like permanent erectile dysfunction and even the possibility of developing prostate cancer. In the U.S., however, FDA warnings still only caution about mild and temporary sexual side effects.

As early as 2006, the Swedish Medical Products Agency began investigating reports of Propecia causing permanent sexual dysfunction; in 2008, they required Propecia manufacturer Merck to include a warning about that potential side effect on all product labels and information. In 2009, when the Swedish study decisively concluded that Propecia caused permanent sexual dysfunction in a significant number of users, Merck changed their product labeling in the United Kingdom and Italy.

Despite well documented evidence of this serious side effect of Propecia, Merck has not issued any warning regarding permanent sexual dysfunction long after stopping use of the drug. As a result, American physicians are still prescribing Propecia to millions of unsuspecting men each year. Neither patients nor doctors in the U.S. have received updated drug information containing warnings about permanent sexual side effects. Worse still, as the debate increases over the safety of Propecia, Merck has decided to pull the Propecia website from public view, so that users cannot even see basic drug information.

Merck's history with Propecia has been murky at best. Approved in 1997, Propecia
(which earns over $400 million in sales annually) was allowed on the market despite the fact that Merck didn't conduct any long-term investigations into potential side effects. Worse still, at the time it was approved, Dr. Michael Weintraub, the FDA's chief of dermatologic drugs, petitioned the FDA to reconsider the approval because of potential safety concerns. An additional plea by University of Pennsylvania Professor Dr. Sherman Frankel came three years later. He asked the FDA to reconsider Propecia's sale to the public because the medication contained more than 20 times the amount of the active drug finasteride necessary to promote hair growth. Both appeals were denied.

Houston-based Propecia attorney Kurt Arnold, of Arnold & Itkin LLP, says he is "shocked that Propecia continues to be made available to young men without any warnings of the serious side effects it could produce. I would urge Merck to protect the public and alter its Propecia labeling to include findings on the drug's potentially permanent side effects." Jason Itkin advises any individual who has been injured as a result of Propecia use to contact an attorney immediately. "At Arnold & Itkin LLP, we are able to help victims of dangerous drugs like Propecia recover financial compensation for their injuries," he said. "Working with an experienced drug attorney is your first and best option for winning justice." At Arnold & Itkin LLP, your first consultation is always free, so call today. One of our drug injury attorneys will be glad to speak with you and advise you on your best course of legal action. We have helped numerous victims of dangerous drugs, and we can help you too. Contact us today.