The European Medicines Agency (EMA) has initiated a review of finasteride, a drug used to treat male pattern baldness and enlarged prostate, to investigate potential links between the drug and suicidal thoughts and behaviors, Bloomberg reports.
The review comes in response to growing concerns about the drug’s potential psychiatric side effects. While finasteride’s product information already lists depression as a known risk, the EMA is now examining the evidence surrounding suicidal ideation.
Drugs containing finasteride and dutasteride when taken by mouth have a ‘known risk of psychiatric side effects, including depression,'” the EMA said in a statement. Suicidal ideation has been added as a potential side effect for two finasteride-containing drugs, Propecia and Proscar.
The EMA’s review will encompass all available evidence to determine whether authorizations for these drugs should be maintained, modified, suspended, or withdrawn within the European Union.
Meanwhile, Britain’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has also issued guidance to men taking finasteride, advising them to “stay vigilant” for potential psychiatric and sexual side effects. The MHRA announced in April that a new patient alert card would be included in finasteride packaging this year. Notably, only oral finasteride is approved in the UK, not the topical version.
Generic finasteride is available from numerous manufacturers, while the brand-name drugs Proscar and Propecia are both produced by Merck (known as MSD outside North America).
