EU drugs regulator confirms suicidal thoughts as side effect of anti-hair loss drug

Exterior view of the European Medicines Agency, EMA, in Amsterdam's business district, Netherlands, Tuesday, April 20, 2021. (AP Photo/Peter Dejong)

The European drugs regulator said on Thursday its safety panel has confirmed suicidal thoughts as a side effect of anti-hair-loss drug finasteride and its generic versions, following an EU-wide review of available data.

Most cases of suicidal thoughts 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 could not be determined from available data, the European Medicines Agency said.

The health agency said in October last year it was reviewing anti-hair-loss drugs finasteride and dutasteride over the risk of suicidal thoughts.

The drugs have a known risk of psychiatric side effects. Finasteride, which Organon sells under brand name Propecia, already comes with warnings about the risk of suicidal thoughts.

The EMA, however, added that it was not possible to establish a link between suicidal ideation and dutasteride tablets based on the reviewed data.

British drugmaker GSK sells dutasteride under brand name Avodart.

Generic versions of finasteride and dutasteride are available in the market.

Organon and GSK did not immediately respond to Reuters’ requests for comment on EMA’s statement.

Finasteride and dutasteride are also used to treat a prostate condition called benign prostatic hyperplasia.

The panel agreed that suicidal thoughts should be included as a side effect for finasteride tablets, but said the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses.

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.

Information about the mood changes seen with finasteride will also be added to dutasteride’s product information as a precaution.

(Reporting by Sneha S K in Bengaluru; Editing by Shinjini Ganguli and Shailesh Kuber).