The U.S. Food and Drug Administration (FDA) announced that the labels for Merck & Co.’s male baldness drugPropeciaand enlarged prostate therapy Proscar will be updated to warn of their link to sexual dysfunction even after drug use has ceased.
The FDA said Propecia’s label will include warnings about orgasm, libido, and ejaculation disorders that may occur even after patients stop using the drugs, according to Bloomberg. The label for Proscar will warn about the increased risk of a decreased libido. Both dangerous drugs will also outline reports of poor semen quality that normalized after drug use stopped as well as reports of infertility.
The agency says in the statement: “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.”
From 1998 to 2011, the FDA reviewed 421 cases of sexual dysfunction stemming from Propecia.