Europe’s medicines regulator has launched an investigation into whether drugs used to treat hair loss in men may be linked to suicidal thoughts and behavior.
The European Medicines Agency’s review of finasteride, which is available as both a tablet and a solution that can be applied directly to the skin, comes after concerns were raised about the drug’s potential link to suicidal thoughts. I did. Finasteride can also be used to treat men with enlarged prostate. Another drug called dutasteride is also used to treat enlarged prostates and is also under review by the EMA.
Taking drugs containing finasteride and dutasteride by mouth “has a known risk of psychiatric side effects, including depression,” the regulator said in a statement. Suicidal thoughts have already been added as a possible side effect to the product information for two drugs containing finasteride: Propecia and Proscar.
The EMA has now said it will consider all evidence to decide whether the authorization of these medicines in the European Union should be maintained, varied, suspended or withdrawn.
Meanwhile, Britain’s medicines regulator has told men taking finasteride to “remain vigilant” about possible psychological and sexual side effects. The UK’s Medicines and Healthcare products Regulatory Agency announced in April that new patient warning cards will be introduced on finasteride packs this year. Only oral finasteride is licensed in the UK, no topical products.
Generic finasteride is available from several manufacturers, under the brand names Proscar and Propecia, both manufactured by Merck & Co., known as MSD outside North America.
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