FDA requires disclosure of suicide risk for anti-baldness drug -Breaking
By Dan Levine
(Reuters.) The U.S. regulators denied a request to withdraw the popular anti-baldness medication Propecia from the marketplace. But, for the first-time ever, patients were required notification regarding suicidal behavior among men using the drug.
Revisions to Propecia labelling have been approved by the U.S. Food and Drug Administration. These labels warned of suicide and persistent sexual dysfunction. A patient advocacy group, the Post-Finasteride Syndrome Foundation, petitioned the FDA in 2017 to order Merck & Co to either stop selling the drug or require far stronger warnings, citing several scientific studies. Propecia’s generic name is Finasteride.
FDA responded this week to the petition by saying that it “doesn’t provide reasonable evidence” linking Propecia with persistent sexual problems, depression, or suicide. The FDA said that the FDA is “requiring suicidal behavior and ideation” be added to Propecia’s list of adverse effects based upon patient reports.
Organon, Merck’s spinoff from Merck, stated Friday it stood behind Propecia and worked with FDA “to find the best route forward.” The representatives of the Post-Finasteride Syndrome Foundation couldn’t be reached immediately. FDA did not respond to our request for comment.
According to an internal risk management assessment, Merck had already identified more than 200 cases of depression in Propecia users as early 2009 according to court documents that were made public by Reuters.
Two years following the Merck risk assessment, FDA analysts disagreed on adding suicide warnings. However, the regulator eventually agreed with Merck’s assertion that suicide rates were lower than expected in this group of patients. The FDA received over 700 suicide reports and thoughts of suicide from people who took the drug.