March 8, 2012 — An article published today in the Examiner highlights efforts made by the U.S. Food and Drug Administration (FDA) to respond to members of the public who contact the administration regarding Propecia sexual side effects. Many of these men are suffering from Post-Finasteride Syndrome, which may include persistent erectile dysfunction and other severe sexual side effects.
Though officials at the FDA and Merck have not yet responded to the Examiner’s inquiries, sources close to the investigation claim that the FDA has responded to hundreds of individual men. They have all received a form letter, which reads in part:
“We are sorry to learn about your experience with the drug Propecia (finasteride) and the difficulties that you are now enduring. As you may already know, sometimes, additional side effects and safety issues that were not identified in clinical studies may occur after a drug is marketed.”
The FDA urges men who have suffered Propecia side effects to submit their adverse event report online via the MedWatch website (http://www.fda.gov/Safety/MedWatch/default.htm). People who wish to submit a report by clicking ‘Reporting Serious Problems to FDA’, then ‘Reporting by Consumers.’
The FDA compiles adverse event reports submitted to the Medwatch website. They use this information to identify clusters of side effects. These reports help the FDA identify unexpected side effects, or specific groups of people who may be more likely to suffer side effects. If the FDA determines that a medication or product poses a risk to public safety, they have the power to take regulatory action. The FDA may issue a Drug Safety Communication. They may also ask a drug-company to update the warning label on the medication, so new users are adequately warned of the potential risk.
At this point, the label on Propecia warns of “persistent erectile dysfunction,” and other sexual side effects. However, some men who have suffered these sexual side effects have complained that their symptoms did not resolve when they stopped taking Propecia. Some men are asking how the FDA and Merck will address these concerns.
The Examiner article also lists two contacts at the FDA for men who are interested in contacting the administration.
- Tatiana Oussova, M.D., M.P.H., Deputy Safety Director, Division of Dermatology and Dental Products, Center for Drug Evaluation and Research, FDA, Tatiana.email@example.com : Dr. Oussova is in charge of the FDA’s review of Propecia safety. Unfortunately, she is not allowed to respond to phone calls, letters, or emails from members of the public. However, she is allowed to read emails
- Dr. Kavita Dada is the FDA liaison with the public for matters regarding the administration’s review of Propecia safety and side effects. If you wish to contact Dr. Dada, she is the FDA employee responsible for responding to the public’s phone calls and emails.
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