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FDA Expands Propecia Sexual Side Effects Probe

The FDA this week expanded its safety review of Propecia, according to an article published today in the Examiner.

March 8, 2012 – The U.S. Food & Drug Administration (FDA) this week expanded its safety review of Merck’s controversial hair loss drug Propecia (generic: finasteride), according to an article published today in the Examiner (examiner.com). While neither the FDA nor Merck has responded to the publication’s previously submitted questions about the drug, sources close to the investigation confirm that the administration has responded to hundreds of men who have inquired about Propecia’s potential for sexual side effects. In recent months, Propecia has been increasingly linked to impotence, erectile dysfunction, gynecomastia, and a number of other severe complications.

Propecia Update 5/22/12: The parents of a former Propecia user who committed suicide after suffering from persistent sexual side effects is blaming the widely-prescribed hair loss treatment for their son’s action. Twenty-two-year-old Randy Santmann killed himself in 2008 within a week of being released from a psychiatric facility, and just six months after discontinuing treatment with Propecia. Click here to learn more.

Propecia Update 5/18/12: In an attempt to bring nationwide attention to the severe sexual complications caused by Propecia, a Las Vegas man has staked himself outside Merck’s headquarters in New Jersey. Kevin Malley, 30, began his self-proclaimed ‘hunger strike’ earlier this week, indicating that he had stopped eating on May 13 to protest Merck’s failure to acknowledge Propecia’s inherent dangers. Click here to learn more.

Free Propecia Lawsuit Evaluation: If you or a loved one has suffered from sexual side effects or other serious injuries you feel may have been caused by Propecia, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Propecia and we can help.

What’s the problem?

According to the Examiner article, the FDA has responded to inquires about Propecia’s sexual side effects with a form letter that says, 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 reportedly goes on to urge anyone affected by Propecia’s side effects to file their case with the MedWatch reporting system. These cases will be added to the administration’s post-marketing safety database and subsequently 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.”

Additionally, the Examiner article stated that FDA employee Dr. Tatiana Oussova will be in charge of conducting the administration’s Propecia safety review. Although she is not allowed to respond to phone calls or e-mail inquires from the public, she is authorized to read e-mails addressed to her. Dr. Oussova’s contact information is as follows:

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 employee in charge of interacting with the public regarding the administration’s Propecia safety review. Inquires may be submitted via e-mail or phone call. Dr. Dada is responsible for responding to such inquiries. Her 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

Want to learn more about Propecia side effects?

Please visit our home page where we provide an overview of the Propecia lawsuit. Here we have posted a number of videos, links to studies and research, and related information: Propecia Lawsuit

Do You Have a Propecia Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Propecia lawsuits. We are handling individual litigation nationwide and currently accepting new sexual dysfunction and cancer cases in all 50 states.

Remember, taking a drug like Propecia to treat hair loss shouldn’t lead to permanent sexual dysfunction or cancer. Our law firm is passionate about helping the large number of otherwise healthy men who have suffered from the serious and potentially irreversible side effects of Propecia.

If you or a loved one has suffered from sexual dysfunction or been diagnosed with cancer after taking Propecia (finasteride) or Proscar, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help. We offer a Free Confidential Case Evaluation.

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