The European Medicines Agency (EMA) has launched a review of medications containing finasteride and dutasteride, commonly prescribed for hair loss and benign prostatic hyperplasia (BPH), following concerns raised about a potential link to suicidal thoughts. The review encompasses drugs like Organon's Propecia and Proscar (finasteride), and GSK's Avodart (dutasteride), assessing whether their marketing authorizations should be altered or withdrawn.
The safety review was prompted by the French medicines agency, which, despite acknowledging the absence of an established causal link, highlighted new safety assessments suggesting a “reasonable possibility” of a connection between these drugs and suicidal ideation. This concern is amplified by the fact that hair loss, for which these drugs are often prescribed, is not considered a serious condition, and the medications are typically administered to otherwise healthy men.
Finasteride and dutasteride share a similar mechanism of action, and psychiatric side effects are already recognized risks associated with their use. Suicidal ideation was recently added to the product information for both Propecia and Proscar in the EU. The French regulators, however, argue that emerging safety reports could “seriously alter the risk profile of finasteride.”
Organon has responded to the review by affirming its commitment to the safety of its finasteride products and pledging to cooperate fully with the EMA throughout the review process. In a statement to Endpoints News, the company emphasized that regulatory agencies globally have thoroughly reviewed the safety and efficacy data for these medicines prior to approval and continue to monitor them through post-marketing surveillance.
The FDA previously declined a petition in 2022 to remove Propecia from the market, stating that there was no reasonable evidence to support a causal association between finasteride and depression. However, the agency did mandate a label update to include suicidal ideation and behavior as potential side effects.
The EMA's review will determine whether the marketing authorizations for finasteride and dutasteride-containing products should remain unchanged, be modified, or be withdrawn across the European region. The outcome of this review could have significant implications for the treatment of hair loss and BPH, potentially impacting millions of patients.
