REGULATORY UPDATE
Finasteride Manufacturer Organon Flees French Propecia Market, Rather than Comply with Federally Mandated Red-Box Warning
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But generics, unfazed by front-facing disclosure that their products ‘can cause psychiatric and/or sexual disorders,’ stay put |
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May 25, 2023
Dear Friends:
French resistance to burying Propecia’s sexual and neuropsychiatric side effects apparently proved too much for the medication’s manufacturer.
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Yesterday, drug-regulatory authority ANSM issued a news update (English) noting that Organon & Co. (NYSE: OGN), the Merck & Co. spinoff that owns original finasteride products Propecia and Proscar, “has discontinued the marketing of Propecia 1 mg (84 tablets) effective January 31, 2023, as well as of Propecia 1 mg (28 tablets) effective April 27, 2023.”
Organon’s retreat from France came in the wake of ANSM’s December 2 mandate that, as of April 28, all finasteride 1 mg products contain a red-box warning on the packaging’s front face that 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.
That QR code links to ANSM’s dossier of educational materials on the growing number of adverse drug reactions (ADRs) to finasteride 1 mg, as experienced by PFS patients.
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The agency, in collaboration with French patient-advocacy group Aide for Victims of Finasteride (AVFIN), first launched that content in July 2022, marking the most thorough and vigilant PFS-awareness campaign ever produced by a drug regulatory authority (DRA). It’s housed on ANSM’s website in six parts:
Among the content presented in ANSM’s news update yesterday was the patient information sheet for finasteride 1 mg (English), last updated in October 2022. It notes that:
Mental disorders can…appear during treatment with finasteride, such as anxiety, depression, and/or suicidal thoughts that may lead to suicide. All of these disorders can have an impact on your social life.
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The news update also notes that, although Organon has folded its Propecia operations in France, generic versions of finasteride 1 mg are still available at French pharmacies.
Organon Director of Global Media Relations Karissa Peer did not respond to our request for comment on the company ceasing Propecia sales in France.
“We are of the opinion that the scientific data does not show a causal connection.”
Merck spun off its Organon subsidiary as an independent public company in June 2021. Originally founded in the Netherlands in 1923, as Organon International, the company today touts its vision as "A better and healthier every day for every woman" while sporting the tagline "Here for her health."
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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.
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Finally, if you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: [email protected]
Thank you.
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