The U.S. Food and Drug Administration announced this week that it is requiring changes to the labels of Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg). The changes will expand the list of sexual adverse events reported to the FDA—some of which have been reported as continuing even after consumers discontinue using the drugs.
Propecia was approved by FDA in 1997 for use in males only and is indicated for the treatment of male pattern hair loss.
Proscar was approved by FDA in 1992 and is indicated for the treatment of bothersome symptoms in men with benign prostatic hyperplasia (also referred to as BPH or an enlarged prostate). Proscar is also approved to reduce the risk of urinary retention or the need for surgery related to BPH.
The FDA indicated that the label changes will 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.
- Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs. Information about these adverse events may be important to individual patients. Therefore, prescribers and patients need to be aware of them, as part of a discussion of risk and benefits of finasteride when determining the best treatment options.
The FDA indicated that some similar side effects are already listed on the labels of the two medications. “Sexual side effects were reported by patients during clinical trials, and this information was included in the Proscar and Propecia’s labels at the time of approval in 1992 and 1997, respectively,” the FDA indicated in a release. “In controlled clinical trials, these side effects resolved in patients who stopped finasteride, as well as in most patients who continued therapy. In 2011, both Proscar and Propecia’s labels were revised to include erectile dysfunction that continued after drug discontinuation.”
Only a small percentage of men using Propecia or Proscar experience sexually adverse events, the FDA said. In the analysis of controlled clinical trials, the FDA determined that 3.8 percent of men reported one or more adverse sexual experiences while on Propecia, as opposed to 2.1 percent who received a placebo in the trials. Sexually adverse events associated with Proscar were identified in two clinical trials, the FDA said, with the adverse events occurring more frequently during the first year of treatment in one trial as opposed to those receiving a placebo. In years two through four, however, there was found to be no significant difference between groups in the incidences of impotence, decreased libido and ejaculation disorder.
Individuals with questions and concerns should consult their health care provider, the FDA said, to discuss the risks and benefits of the medication as they specifically apply to the individual. The FDA warns patients: Do not stop taking your medication without first consulting with your health care provider.
Despite the new label information, the FDA indicates that finasteride remains a safe and effective drug for its approved indications. However, healthcare professionals and patients should consider this new label information when deciding the best treatment option.
Patients and healthcare professionals should report adverse events experienced with Proscar or Propecia to the FDA MedWatch program. Reports can be made via 1-800-332-1088; online at MedWatch Online; or regular mail and postage-paid FDA Form 35002.
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