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EU drugs regulator confirms suicidal thoughts as side effect of hair loss drug
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EU drugs regulator confirms suicidal thoughts as side effect of hair loss drug
May 26, 2025 4:15 AM

May 8 (Reuters) - The European drugs regulator said on

Thursday its safety panel has confirmed suicidal thoughts as a

side effect of the drug finasteride and its generic versions

used as a treatment for hair loss, following an EU-wide review

of available data.

Most cases of suicidal ideation were reported in people

using 1 milligram (mg) finasteride tablets, which are used to

treat androgenetic alopecia - a condition of hair loss brought

on by male hormones.

The frequency of the side effect is unknown, meaning that it

is not possible to estimate it from available data, the health

agency added.

A patient card will be included in the packages of 1 mg

finasteride tablets to remind patients of these risks and to

advise them about the appropriate course of action, the health

regulator said.

The European Medicines Agency in October last year said

it was reviewing anti hair-loss drugs, finasteride and

dutasteride, over the risk of suicidal thoughts.

The drugs are sold under the brand name Propecia

(finasteride) by Organon, and as Avodart (dutasteride)

by British drugmaker GSK. The generic versions of these

drugs are available in the market.

The EMA, however, added that it was not possible to

establish a link between suicidal ideation and dutasteride based

on the reviewed data.

The regulator said information about the mood changes seen

with finasteride will also be added to dutasteride's product

information as a precaution.

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