It can contain a carcinogenic substance

Tuesday, July 29, 2025, the National Medicines Safety Agency (ANSM) said in a statement that prizes of an antidepressant, the Ludiomil (Maprotiline) are recalled.

“Type impurities Nitrosamine », classified as probable carcinogenwere found. Consequently, this antidepressant “will no longer be available”.

Consult a doctor before changing treatment

The ANSM recommends from replace Ludiomil by other antidepressants: amitriptyline (laroxyl and generics) or Mirtazapine (Norset and Generics).

This treatment, indicated in “characterized” depressed “episodes, is currently used by 5 000 patients In France, mostly people over the age of 60, said the drug agency.

The health authority, however, recommends that patients treated by Ludiomil not interrupt the treatment for themselvesbut to consult a doctor who can prescribe another antidepressant under prescription.

Brutal judgment [du traitement] can indeed represent a greater risk than exposure to nitrosamine impurities likely to be present.

Production suspended since March 2025

The production of Ludiomil and its distribution had already been Suspended since late March 2025 Pending confirmation, which fell at the end of June: “The presence of nitrosamine type impurities at rates higher than the standards set by the European authorities”.

Nitrosamines are “classified Probable carcinogens for humans By the International Center for Research on Cancer (CIRC), “the ANSM told AFP. This ranking is “mainly on animal studies, suggesting that prolonged exposure to high concentrations could increase the risk of cancer,” said the drug agency.

Ludiomil’s lots are therefore “recalled and this medication will now be more available ”immediately. The provision of new lots “is expected at best for the end of 2026”, specifies the ANSM.

Source: AFP.

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