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, announced, Tuesday, July 29, the National Agency for Medicines Safety (ANSM). This organization recommends its replacement with other antidepressants: amitriptyline (laroxyl and generics) or Mirtazapine (Norset and Generics).
The Ludiomil, which can be prescribed in the episodes “Characterized depressive”is currently used in the treatment of 5,000 patients in France, mostly people over the age of 60, the ANSM said.
The production of this medication and its distribution had been suspended in late March 2025 pending confirmation, which fell in late June. ANSM is in this antidepressive “The presence of nitrosamine type impurities at rates above the standards set by the European authorities”, specifying the agency France-expense that nitrosamines are “Classified probable carcinogens for humans by the International Center for Research on Cancer”. This classification is based “Mainly on animal studies, suggesting that prolonged exposure to high concentrations could increase the risk of cancer”also said the ANSM.
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 at best for the end of 2026”said 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 “Can indeed represent a greater risk than exposure to nitrosamine impurities likely to be present”.
