FDA Requires Drug Manufacturer to Disclose Risks of Suicidal Behavior to Patients
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
The anti-baldness drug Propecia is currently facing controversy over claims the drug increases rates of suicidal behavior in men. According to a June 2022 article, "FDA requires disclosure of suicide risk for anti-baldness drug", the US Food and Drug Administration (FDA) has rejected a request to remove the drug entirely from the market, but will require the company to notify patients of the reports of suicidal behavior in men.
This is not the first time the FDA has revised Propecia labels. Previously, the revisions included mentions of risks of persistent sexual dysfunction and depression, but not specifically suicide. Since then, the patient advocacy group "Post-Finasteride Syndrome Foundation" petitioned the FDA to order the manufacturing company (Merck & Co) to either alter the drug's label to include much stronger warnings or to remove the drug from the market entirely. The group claims to have cited several scientific studies to back their petition.
According to the same June 2022 article, "FDA requires disclosure of suicide risk for anti-baldness drug":
In a response this week, the FDA said the group's petition "does not provide reasonable evidence" of a causal link between Propecia and persistent sexual problems, depression or suicide. However, based on patient reports, the FDA said it is "requiring the addition of suicidal ideation and behavior" to the adverse reactions listed on Propecia's label.
Merck & Co states they stand behind the safety and efficacy of Propecia, and are working closely with the FDA to determine the next steps of action.
History Surrounding Propecia Label Changes
However, this is not the first time Merck has had to face controversy surrounding the negative effects of Propecia. According to the June 2022 article:
As early as 2009, Merck knew of more than 200 reports of depression, including suicidal thoughts, in men taking Propecia, according to an internal "risk management" assessment from that year, which was contained in court documents made public following a Reuters request.
Furthermore, in addition to the initial reports of depression and suicidal thoughts linked to Propecia in 2009, there was even discussion of adding a warning label for suicide back in 2011:
In 2011, two years after the Merck risk analysis, FDA analysts disagreed about adding a warning related to suicide, but the regulator ultimately agreed with Merck that the number of suicides was lower than one would expect in that group of patients. Since that decision, the FDA has received more than 700 reports of suicide and suicidal thoughts among people taking versions of the drug.
As always, we will continue to monitor the controversy surrounding Propecia and will provide you with any new or relevant information.
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