France Orders ‘Red-Box’ Warning—and QR Code Linking to PFS-Awareness Dossier—Slapped on all Finasteride 1 mg Products by April

Dec. 4, 2022

Dear Friends:

French PFS awareness is going high-tech.

ANSM, the Gallic nation’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.”

3. Risks of taking finasteride 1 mg (English): “Patients have reported sexual disorders when using finasteride 1 mg… Patients have also reported mental disorders, including anxiety, depression, [and] suicidal thoughts that could lead to suicide… All of these disorders can have an impact on social and professional life. Sexual and psychological disorders may persist after stopping treatment for an indefinite period.”

4. Information for patients treated with finasteride 1 mg (English): “It is important to remain vigilant for the appearance of worrying/unusual signs, even if they seem trivial to you… It is also recommended that you inform your relatives that you are taking finasteride…and ask them to alert you if they observe any changes in your behavior.”

5. Information for healthcare professionals about finasteride 1 mg (English): “Remember that finasteride…can cause mental disorders and sexual disorders… [I]t is advisable to schedule a follow-up consultation within three months after initiation of treatment…then regularly (for example, every six months) during treatment.”

6. How to report adverse reactions to finasteride: “[T]his interactive video…provides a step-by-step guide for anyone wishing to report an adverse reaction potentially linked to [finasteride]” to the French Ministry of Health’s portal for adverse health events. Notably, the array of possible adverse reactions presented on page 11 of the video (above) is divided into 44 disorders, ranging from insomnia to tinnitus to memory loss to pudendal neuralgia.

Anyone living in the US who suffers from PFS should report his or her symptoms to the US FDA. Anyone living outside the US who suffers from PFS should report his or her symptoms to the US FDA as well as to his or her local drug-regulatory authority (DRA), as directed on our Report Your Side Effects page.

Finally, if you or a loved one are suffering from PFS and feeling depressed or unstable, please don’t hesitate to contact us via our Patient Support hotline:

Thank you.

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