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FDA Orders New Warnings for Propecia, Proscar Sexual Side Effects

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The U.S. Food & Drug Administration (FDA) just ordered new warnings for Propecia and Proscar sexual side effects. The drugs, known generically as finasteride, treat enlarged prostate and male pattern baldness and have been linked with sexual side effects that some men say is permanent.

Merck’s Propecia and Proscar, along with GlaxoSmithKline’s Avodart and Jalyn are part of the drug class 5-alpha reductase inhibitors (5-ARIs) and were taken, says the FDA, by nearly five million men during 2002-2009.

Propecia and Proscar and their generic and brand equivalents, which have long been linked to some sexual side effects, noted Bloomberg Businessweek, will now have additional information on their labels. The agency says the change is being made because the medications’ side effects are known to continue even after patients stop taking these drugs. The revised label will indicated that some men who took Propecia and Proscar went on to experience libido, ejaculation, and orgasm disorders that persisted after they stopped taking the drug, said Businessweek.

Approved in 1992 to alleviate enlarged prostate symptoms, Proscar is prescribed to minimize risks for urinary retention or surgery in these patients. In 1997, Propecia received approval for the treatment of male pattern hair loss, explained Businessweek. While finasteride has been shown to be effective in minimizing prostate cancer risks, the FDA updated the drug’s label in June 2011 to state that the drug may actually increase risks for a more dangerous prostate cancer.

According to a FAQ issued by the FDA the drugs will be subject to the following label revisions

  • Propecia: Will now include information on libido, ejaculation, and orgasm disorders that continued after discontinuation of the drug.
  • Proscar: Will now include information on decreased libido that can continue after discontinuation of the drug.
  • Propecia and Proscar: Both labels will now include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.

Several Propecia lawsuits have been filed over the last year against Merck & Co. by men claiming the drug caused sexual issues. In additional to associations with sexual dysfunction and high-grade prostate cancer, these drugs have also been associated with increased risks for male breast cancer.

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