Recall of batches of Ludiomil, an antidepressant that will no longer be available by the end of 2026 due to a probable carcinogen

Batches of Ludiomil (maprotiline) are being "recalled" and this antidepressant "will no longer be available" by the end of 2026, due to "the presence of nitrosamine-type impurities" , classified as a probable carcinogen, announced the French National Agency for the Safety of Medicines (ANSM) on Tuesday, July 29. This organization recommends its replacement by other antidepressants: amitriptyline (Laroxyl and generics) or mirtazapine (Norset and generics).

Ludiomil, which can be prescribed for "characterized depressive" episodes, is currently used in the treatment of 5,000 patients in France, the majority of whom are over 60, the ANSM said.

Production and distribution of this drug were suspended at the end of March 2025 pending confirmation, which came in at the end of June. The ANSM noted in this antidepressant "the presence of nitrosamine-type impurities at levels higher than the standards set by the European authorities," specifying to Agence France-Presse reported that nitrosamines are "classified as probable human carcinogens by the International Agency for Research on Cancer." This classification is based "primarily on animal studies, suggesting that prolonged exposure to high concentrations could increase the risk of cancer," the ANSM also reported.

Batches of Ludiomil are therefore being "recalled and this medication will no longer be available" for the time being. The availability of new batches "is expected at best by the end of 2026," ANSM stated.

In its press release, the Medicines Agency recommends that patients treated with Ludiomil do not stop treatment themselves, but rather consult a doctor who can prescribe another prescription antidepressant. "Abruptly stopping" treatment "may in fact represent a greater risk than exposure to nitrosamine impurities that may be present."