Safety Alerts & Recalls

What does this mean?

Sexual dysfunction is a known side effect of Proscar and Propecia and has been included in the prescribing label for these medications since they first were approved by the FDA. The updated labeling now includes the reports of sexual side effects that continue after a patient has stopped taking the drug.

Only a small percentage of men using finasteride products have experienced sexual dysfunction while taking these drugs. For most patients, the benefits of these medicines will outweigh the risks. The FDA believes that finasteride remains a safe and effective drug for its approved indications.

If you currently take Proscar or Propecia or the generic version Finasteride and you have questions or concerns, you should consult your healthcare provider to discuss the risks and benefits of the medication as they specifically apply to you. Do not stop taking your medication without first consulting with your healthcare provider.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Updates Prescribing Information for Finasteride (Propecia, Proscar)

The FDA has announced that the labeling for Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) will be updated with an expanded list of potential adverse events related to sexual function that have been reported both during use and after the drug is no longer being used.

The new label changes include: - A revision to the Propecia label to include sexual function issues including 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.

Clear causal links between finasteride (Propecia and Proscar) and adverse events related to sexual function have NOT been established. However, post marketing reports suggest a broader range and longer duration of adverse effects than previously reported in patients taking these drugs. Information about these adverse events may be important to individual patients. The FDA wants prescribers and patients to be aware of the potential risk of adverse events related to sexual function and include them as part of a discussion of risk and benefits of finasteride when determining the best treatment options.

Proscar and Propecia both contain the active ingredient finasteride and belong to a class of prescription medicines called 5-alpha-reductase inhibitors. Proscar is approved for the treatment of bothersome symptoms in men with benign prostatic hyperplasia (also referred to as BPH or an enlarged prostate) and for the reduction in urinary retention and need for surgery related to BPH. Propecia is approved for the treatment of male pattern hair loss.

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Source: FDA
Publication Date: 2012-04-13
Last Updated: 2012-04-13

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