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FDA: Label changes for finasteride expand list of adverse events

The FDA has announced changes to the professional labels for finasteride, 5 mg (Proscar), and finasteride, 1 mg (Propecia), to expand the list of sexual adverse events reported to the FDA, as some of these events have been reported to continue after the drug is no longer being used.

The new label changes include the following:

  • a revision to the finasteride, 5 mg label, to include decreased libido that continued after discontinuation of the drug
  • a revision to the finasteride, 1 mg, label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug
  • a revision to both labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.

Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have not been established, the cases reviewed by the FDA suggest a broader range of adverse effects than previously reported in patients taking these drugs, the agency said in a statement.

For finasteride, 5 mg, the FDA reviewed 131 cases of erectile dysfunction and 68 cases of decreased libido associated with the use of the drug submitted to the drug sponsor’s worldwide safety database between 1992 and 2010. Regarding semen quality, 251 cases associated with the 1-mg dose were identified from the sponsor’s safety database. Of these, 13 contained enough information for the FDA to evaluate. Twenty-nine cases associated with finasteride, 5 mg, use were evaluated, of which only three involved men with BPH.

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