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EU regulator reviews anti-baldness drugs over concerns of suicidal thoughts
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EU regulator reviews anti-baldness drugs over concerns of suicidal thoughts
Oct 4, 2024 6:18 AM

Oct 4 (Reuters) - The European drugs regulator said on

Friday it was reviewing anti hair-loss drugs, including

Organon's Propecia and its generic versions, over the

risks of suicidal thoughts.

The European Medicines Agency said it would recommend

whether the marketing authorisations for the drugs should be

withdrawn, suspended or maintained across the region following

its review.

Oral anti-baldness drugs called finasteride and dutasteride

have a known risk of psychiatric side effects. Finasteride,

branded as Propecia, already comes with warnings about the risk

of suicidal thoughts.

A patient advocacy group, the Post-Finasteride Syndrome

Foundation, petitioned the FDA in 2017 to order Merck ( MRK ) to either

stop selling the drug or add far stronger warnings, citing

several scientific studies.

Several years later in 2022, the U.S. Food and Drug

Administration rejected a request to remove Propecia from the

market, and ordered a warning about suicidal thoughts and

behavior on the drug's label.

Anti-baldness drugs are sold under the brand name

Propecia, from Organon, and Avodart by British drugmaker GSK

, but also have generic versions available in the market.

Organon, which was spun-off from Merck ( MRK ) in 2021,

and GSK did not immediately respond to a Reuters request for

comment.

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