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