The European Medicines Agency (EMA) has officially confirmed that suicidal thoughts are a potential side effect of the anti-hair-loss drug finasteride, particularly in its 1 mg dosage commonly used to treat androgenetic alopecia. This conclusion follows an EU-wide safety review of finasteride and dutasteride, two drugs known for their psychiatric side effects. While finasteride already carries warnings about such risks, the EMA has now formally added suicidal thoughts as a recognized side effect, although it was unable to determine the frequency from current data. The investigation did not establish a similar link for dutasteride, which is sold by GSK under the name Avodart. Both drugs, along with generic versions, are also used to treat benign prostatic hyperplasia. The EMA decided that despite these risks, the benefits of finasteride and dutasteride still outweigh potential harms for approved uses. To further safeguard patients, 1 mg finasteride packages will now include a patient card highlighting these risks, and precautionary mood-related information will be added to dutasteride’s labeling .
This development aligns with earlier regulatory actions. In June 2022, the U.S. Food and Drug Administration (FDA) mandated a warning about suicidal thoughts and behavior on finasteride’s label, although it declined to remove the drug from the market .
Despite these measures, some experts and patient advocacy groups argue that the risks associated with finasteride have been under-acknowledged. Dr. Michael Irwig, an endocrinologist at Harvard Medical School, criticized Merck’s handling of risk analysis, stating that the company “definitely should have provided a more complete picture” regarding potential psychiatric side effects .
In response to the EMA’s findings, Organon and GSK, the manufacturers of finasteride and dutasteride respectively, have not yet issued public statements.
For individuals in Bangladesh or elsewhere considering or currently using finasteride, it is crucial to be aware of these potential risks. Patients are advised to consult healthcare professionals promptly if they experience any mood changes or suicidal thoughts.
Source : Reuters
