A number of patient advocates, including the Post-Finasteride Syndrome Foundation (PFSF), had petitioned the FDA to remove the anti-baldness drug Propecia (finasteride) from the market.
The FDA recently announced that the drug would remain on the market but agreed to revise the label for finasteride to include a notice about reports of suicidal behavior.
Merck & Co.’s Organon division is the manufacturer of Propecia, which
The agency had earlier agreed to add a warning to the label about the risk of persistent sexual depression and depression.
In September, the nonprofit watchdog group Public Citizen filed a lawsuit on behalf of PFSF, asking FDA to either halt sales of the drug or add new warnings to its label.
Merck won approval to market finasteride (1 mg) to treat male pattern hair loss. A 50-mg dose of the drug initially won FDA approval in 1992 to treat benign prostatic hyperplasia.
In 2001, FDA decided not to include a warning about the potentially elevated risk of suicide tied to finasteride. Since then, the agency has received hundreds of reports related to suicidal patients or suicidal ideation.