The European Medicines Agency (EMA) announced on Thursday that its safety committee has confirmed suicidal thoughts as a potential side effect of the anti-hair-loss drug finasteride and its generic versions, following a review of data across the EU.
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Most reports of suicidal thoughts were linked to the 1-milligram (mg) tablets of finasteride, commonly used to treat androgenetic alopecia, a form of hair loss caused by male hormones. However, the EMA noted that the frequency of this side effect could not be determined from the available data.
The agency launched its review of finasteride and another hair-loss treatment, dutasteride, in October last year over concerns about the risk of suicidal ideation. Both drugs are already known to carry psychiatric side effects. Finasteride, marketed under the brand name Propecia by Organon (OGN.N), already includes warnings about this risk.
Based on the review, the EMA concluded that there was insufficient evidence to establish a connection between suicidal thoughts and dutasteride, which is sold by British pharmaceutical company GSK (GSK.L) under the brand name Avodart. Generic versions of both finasteride and dutasteride are also widely available.
Organon and GSK did not immediately respond to Reuters’ requests for comment on the EMA’s findings.
In addition to treating hair loss, both finasteride and dutasteride are used to manage benign prostatic hyperplasia, a noncancerous enlargement of the prostate.
The EMA’s panel recommended that suicidal ideation be officially listed as a side effect for finasteride tablets. Nevertheless, the agency emphasized that the overall benefits of both finasteride and dutasteride still outweigh their risks for approved indications.
As part of its updated safety measures, the EMA will require a patient card to be included in the packaging of 1 mg finasteride tablets to inform patients about the potential risks and guide them on appropriate actions. Additionally, information regarding mood changes associated with finasteride will be added to the product information for dutasteride as a precautionary step.