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FDA widens Propecia safety probe

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Posted On 07.03.11 by in Propecia Archives

Numerous men who say they have been affected by the permanence of Propecia’s severe side effects have been contacted by the Food and Drug Administration this week as the agency expands its safety review of the Merck manufactured drug.
While both FDA and Merck spokespersons continue to maintain their silence on questions previously submitted by the Examiner, sources close to the investigation confirm that the FDA has responded to the hundreds of men who have emailed the agency in response to the Examiner’s coverage of Propecia’s irreversible sexual side effects.
The emails say, 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 anyone affected by Propecia to “formally document your case via the MedWatch reporting system. The information you provide will be added to FDA’s post-marketing safety database and reviewed by the post marketing safety staff.
 “Review of the database may suggest a signal of an unexpected safety issue or indicate that some individuals experience a known side effect of a drug with greater severity. FDA will carefully evaluate and analyze all reports that are available and take any necessary regulatory actions if warranted.
“You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/Safety/MedWatch/default.htm), click on ‘Reporting Serious Problems to FDA’, then ‘Reporting by Consumers’.”
The Examiner has learned that Dr. Tatiana Oussova is the FDA person responsible for conducting the agency’s Propecia safety review. In accordance with FDA policy, she will not respond to emails or phone calls from the public, but she will read the emails that are addressed to her. Dr. Oussova’s title and contact information is: Tatiana Oussova, M.D., M.P.H., Deputy Safety Director, Division of Dermatology and Dental Products, Center for Drug Evaluation and Research, FDA, Tatiana.oussova@fda.hhs.gov
Dr. Kavita Dada is the FDA person responsible for interacting with the public regarding the agency’s ongoing Propecia safety review. Men affected by Propecia may either email or call Dr. Dada by phone. It is Dr. Dada’s job to return phone calls and respond to emails from the general public. Contact information is: Dr. Kavita Dada, Pharm. D., Senior Health Promotions Officer, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 301-796-3105, Kavita.Dada@fda.hhs.gov
The Examiner will continue to report on this developing story and will post an update as new information is received from the FDA or Merck.

 



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