FDA Updates Labels on Propecia and Proscar

April 11, 2012 —  The FDA previously updated the safety information for Propecia and Proscar in 2011, when the labels were revised to include information about persistent erectile dysfunction that continued after the drugs were discontinued. The revised labels expand the list of persistent sexual problems that did not resolve after discontinuation of Propecia or Proscar, and warn of fertility problems while taking the drugs.

The revised labels for Propecia and Proscar will include the following information:

• Propecia label will include warnings about libido disorders, ejaculation disorders, and orgasm disorders that continue after discontinuation of the drug.
• Proscar label will include warnings about decreased libido after discontinuation of the drug
• Both Propecia and Proscar labels will describe reports of male infertility and/or decreased semen quality that normalized or improved after discontinuation of the drug

The FDA decision was based upon 421 post-marketing reports submitted via the Adverse Event Reporting System (AERS). The reports were submitted between 1998 and 2011. The reporting is voluntary, and may be submitted by health care professionals or consumers. When reports are submitted, they are reviewed by specialists who monitor the safety of products approved by the FDA. When potential safety concerns are identified, the FDA usually updates the safety labeling, as it has with Propecia and Proscar.

The FDA reviewed the following reports of adverse events related to Propecia and Proscar:

• Propecia: 59 cases reported sexual dysfunction for three months or longer after discontinuation of Propecia. Symptoms included erectile dysfunction, decreased libido, problems with ejaculation, orgasm disorders
• Proscar: 131 cases of erectile dysfunction, 68 cases of decreased libido
• Clinical trials showed that during treatment with Propecia, 3.8% of men reported at least one adverse sexual event, compared with just 2.1% of non-Propecia users
• In clinical trials of Proscar, sexual adverse events were noted in two trials. Adverse events were most frequent during the first year of treatment, but there was no difference among Proscar and non-Proscar users after 2-4 years.

Propecia and Proscar both contain finasteride, a drug that experts linked to sexual dysfunction when the drugs were approved, in 1992 and 1997, respectively. Although this information was included in the original safety labels, it was not until after millions of men had used the drugs that the FDA began receiving reports of persistent sexual dysfunction that did not resolve when men discontinued the drugs. In what many men are now calling Post-Finasteride Syndrome, a small subset of men using Propecia or Proscar suffer an “endocrine system crash” after discontinuation of the drugs, followed by severe physical, sexual, and psychological changes that are difficult or impossible to treat.