Regulators are waking from their slumber

Agencies in France, the United Kingdom, Canada and the United States are strengthening warnings about finasteride risks

On April 28, the French drug regulator ANSM will add a red box warning to the packaging of finasteride as a treatment for hair loss. The agency has published a patient information sheet on risks including sexual and psychiatric disorders, and provides detailed instructions on how to report adverse events. These safety measures were developed with the participation of the French Organization for Victims of Finasteride, AVFIN. Three news items on the group’s website, in French, provide more details on the changes (January, July 6 and November 30, 2022).

Left: red box warning to be added to finasteride (1 mg) packaging in France on April 28, 2023.

In March, the U.S. Food and Drug Administration website noted that the agency will host a Patient Listening Session on post-finasteride syndrome (archived version). The page explains: “Patient Listening Sessions help the Agency inform medical product development, clinical trial design, patient preferences, and shape our regulatory thinking. …FDA staff will either ask questions or simply listen to better understand your experiences and perspectives. Only the FDA, patients, caregivers, advocates, and community representatives participate in the session.”

FDA’s note on an upcoming Patient Listening Session on post-finasteride syndrome

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a safety review, as reported by the Daily Mail in March. The PFS Foundation has reported that a Medical Assessor wrote the following to patient-advocates (emphasis added):

This topic was discussed at our recent signal meeting and has led to several action points which we are currently undertaking[:]

• Assessment of the available scientific literature

• Review of the documentation on safety and risk required to be produced by [drug makers] under the Human Medicines Regulation 2012

• Consideration and review of the adverse drug reaction reports

• Review of assessments and actions undertaken by other regulatory authorities

• Consideration of concerns raised to our attention via other sources such as healthcare professionals, individuals, patient representative groups, other stakeholders

• Engagement with relevant clinical and scientific experts, patients and patient representative groups

A review by Health Canada found a “possible link between the use of finasteride & the risks of suicidal ideation and self-injury.” Here is an excerpt from the review’s key messages:

Health Canada’s review…found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury. At this time, there is not enough information to establish a link for the risk of suicide.

Health Canada is working with the manufacturers to update the product safety information in the Canadian product monographs (CPM) for finasteride-containing products to strengthen the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors prior to starting treatment, as well as continuous patient monitoring during and after stopping treatment. 

Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.