Ludiomil prizes (Maprotiline) are “Recalled” and this antidepressant “Will no longer be available” by the end of 2026 due to “The presence of nitrosamine type impurities”, Classified as probable carcinogen, the National Agency for Medicines (ANSM) announced on Tuesday July 29, July 29. The body recommends its replacement with other antidepressants, such as amitriptyline (laroxyl and generics) or mirtazapine (norset and generics).
The Ludiomil, indicated in the episodes “Characterized depressive”, is currently used in the treatment of 5,000 patients in France, mostly people over 60, specifies the drug agency.
The production of this medication and its distribution had already been suspended since the end of March 2025 pending confirmation, fallen at the end of June: “The presence of nitrosamine type impurities at rates above the standards set by the European authorities”.
Nitrosamines are “Classified probable carcinogens for humans by the International Center for Research on Cancer (CIRC)”, said the ANSM. This classification is based “Mainly on animal studies, suggesting that prolonged exposure to high concentrations could increase the risk of cancer”, again lets the drug agency know.
Ludiomil’s batches are therefore “Recalled and this drug will no longer be available” in the immediate future. The provision of new lots “Is expected as well as possible for the end of 2026”, still specifies the ANSM.
In its press release, the drug agency recommends that patients treated with Ludiomil not interrupt the treatment for themselves, but to consult a doctor who may prescribe another prescription antidepressant. “Brutal judgment” treatment “May represent a greater risk than exposure to nitrosamine impurities likely to be present”.
