April 11, 2012 — Today, the U.S. Food and Drug Administration (FDA) announced that it would be adding more warnings about the risk of persistent sexual side effects after using Propecia or Proscar. The revised safety labels were prompted after hundreds of men reported problems with libido, ejaculation, and orgasm that did not resolve when they discontinued the drug. The FDA statement says, “the cases suggest a broader range of adverse events than previously reported in patients taking these drugs.”
The last time the FDA updated the labels for Propecia or Proscar was in 2011, to include a warning about the risk of persistent erectile dysfunction that did not resolve when men stopped taking Propecia or Proscar. The new labels will include the following sexual side effect information:
- Propecia: The new labels will warn about the risk of problems with libido, ejaculation, and orgasming that does not resolve when the medication is stopped.
- Proscar: The new labels will warn about the risk of decreased libido that does not resolve when the medication is stopped
- Propecia and Proscar: Both drugs’ labels will be changed to warn about the risk of male infertility and poor semen quality while taking either of these medications, but the problems normalized or improved after stopping the medications
The revisions to the safety labels was prompted by 421 reports that were submitted to the agency through the Adverse Event Reporting System (AERS), in which injured people or health care professionals voluntarily inform the FDA of side effects with drugs or medical devices. Specialists at the FDA review these reports, and when safety concerns are identified, the FDA usually makes changes to the drug information label.
The labeling updates were based upon the following adverse event reports:
- Propecia: There were 59 reports of sexual dysfunction that persisted for at least 3 months after Propecia was discontinued. Side effects reported were erectile dysfunction, decreased libido, difficulty ejaculating, and problems orgasming
- Proscar: There were 131 cases of persistent erectile dysfunction, and 68 reports of men suffering from decreased libido. These problems did not resolve once Proscar was discontinued
- In clinical trials of Propecia, 3.8% of men taking Propecia had one or more adverse sexual event. Only 2.1% of men who were not taking Propecia had a sexual side effect in the same time period
- Two clinical studies have noted sexual side effects in men taking Proscar. Sexual side effects were most common during the first year. After two to four years of treatment, the risk of sexual side effects was the same for men taking Proscar and men not taking Proscar
Propecia contains 1-mg of finasteride, and Proscar contains 5-mg of finasteride. In the initial clinical studies of finasteride, researchers noted that some men suffered sexual side effects. Each drug’s initial warning label included this risk information. The warnings assured men that the sexual side effects would resolve once Propecia or Proscar were discontinued. It was only after millions of men had used Propecia or Proscar that experts started to note that more and more men were reporting persistent sexual side effects. A subset of men suffer a disorder they are calling Post-Finasteride Syndrome, in which men who discontinue Propecia or Proscar have an “endocrine system crash,” which is soon followed by significant changes to their physical, mental, and sexual health. These changes are very difficult to treat and often severely harm a man’s quality of life.
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