French PFS awareness is going high-tech.
ANSM, France’s drug-regulatory authority (DRA), last week unveiled plans to add a so-called “red-box” warning—that includes a QR code—on all finasteride 1 mg products in 2023.
Intended to “reinforce information on adverse effects” of Propecia and generics, the warning reads:
This medication can cause side effects, including psychiatric and/or sexual disorders. To find out more about these effects and report them, consult the leaflet, and scan this QR code.
“On April 28, 2023 at latest, all boxes of medicine containing finasteride 1 mg will include [this warning] on their main (front) face,” ANSM announced (English) Friday.
ANSM’s QR code—the first known use of such technology in finasteride labeling—links to a dossier of educational materials on the growing number of adverse drug reactions (ADRs) to finasteride 1 mg, as experienced by PFS patients.
The agency, in collaboration with French patient-advocacy group Aide for Victims of Finasteride (AVFIN), first launched that content in July, marking the most thorough and vigilant PFS-awareness campaign ever produced by a DRA. It’s housed on ANSM’s website in six parts:
1. Finasteride 1 mg for the treatment of early-stage hair loss (English): “Considering the impact that some of the adverse reactions associated with finasteride can have on the patient’s quality of life, it is essential to be aware of them before starting treatment. By the same token, it is important that a rigorous and regular medical follow-up is conducted during treatment.”
2. Finasteride 1 mg and hair loss (English): “[A]lthough the desired action of finasteride is the reduction of the level of DHT in hair follicles, other organs can be impacted. If drugs based on finasteride 1 mg manage…to combat androgenetic alopecia, the hormonal action of finasteride could be the cause of sometimes severe adverse effects.”
