New Sexual Adverse Effects Added to Finasteride Labels — Physician’s First Watch
New Sexual Adverse Effects Added to Finasteride Labels
The labels of the alopecia drug Propecia (finasteride 1 mg) and the benign prostatic hyperplasia drug Proscar (finasteride 5 mg) are being updated with an expanded list of adverse sexual effects, the FDA has announced.
The Propecia label will include libido, ejaculation, and orgasm disorders that persist after treatment ends.
The Proscar label will include decreased libido that persists posttreatment.
Both labels will note reports of male infertility or poor semen quality that improved after drug discontinuation.
The FDA said: "Despite the fact that clear causal links between finasteride ... and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported."
When these drugs were approved in the 1990s, their labels noted sexual side effects that normalized after treatment ended. In 2011, the FDA updated the labels to warn of persistent, posttreatment erectile dysfunction.