12:07 PM EDT, 10/04/2024 (MT Newswires) -- (Updates with Organon's response in the fifth and sixth paragraphs.)

Organon's (OGN) finasteride-containing Propecia product is under review in Europe over the ingredient's link to the risk of suicidal thoughts and behaviors, according to a Friday statement from the European Medicines Agency, or EMA.

The regulator said it is reviewing medicines containing finasteride and dutasteride over their potential psychiatric side effects, which include depression. Propecia is indicated for the treatment of male-pattern hair loss and the EMA said its updated product information now includes suicidal ideation as a possible side effect.

GSK's (GSK) Avodart product is also under review by the EMA, according to Reuters.

The EMA said it will assess all available data on the medicines and issue a recommendation afterwards on whether the medicines' marketing authorizations should be revoked, suspended, revised or maintained in Europe.

In an emailed response to MT Newswires, a company spokesperson said that the company stands behind the safety and efficacy of its finasteride medicines, adding that regulators around the world have reviewed the safety and efficacy data for these medicines prior to their approval.

"Nothing is more important to Organon than the safety of our medicines and the people who use them," the spokesperson said.

GSK did not immediately respond to MT Newswires' request for comment.

Price: 18.37, Change: +0.11, Percent Change: +0.60