FDA updates risks of adverse effects from treatment with finasteride

The U.S. Food & Drug Adminstration (FDA), yesterday, issued a statement about modifications to the labeling (the product prescribing information) for the two branded formulations of finasteride: Propecia® (finasteride 1 mg) and Proscar® (finasteride 5 mg). These modifications to the product labeling may be relevant to some men with or at risk for prostate cancer.

The full FDA statement is available on the FDA’s web site, complete with additional information about the labeling changes in the form of relevant questions and answers.

Basically, the FDA has required Merck, the manufacturer of Proscar and Propecia, to expand the list of possible sexual adverse events listed in the product prescribing information  to include the following:

  • A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug
  • A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug
  • A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation

We should be clear that there are no established causal links between treatment with finasteride and subsequent sexual adverse events; however, patient case data reported to the FDA do suggest a broader range of adverse effects than previously reported in patients being treated with Proscar and Propecia. Prescribing physicians and patients need to be aware of the possible risk for these side effects, and discussion of risk and benefits of finasteride is appropriate between doctor and patients when determining possible and appropriate treatment options.

Patients who are already receiving treatment with finasteride also need to understand that this change to the prescribing information also applied to generic formulations of finasteride.

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