Its nitrosamine levels are higher than the standards set by the European authorities.
“Currently 5,000 patients, mostly people over the age of 60, are treated by this drug in France” Remember the Medicines Agency in a statement published in late July. This was informed of “The presence of nitrosamine type impurities at rates above the standards set by the European authorities” in the batches of the drug. These lots are recalled and this medication is removed from the market.
As part of this recall, ANSM, in collaboration with health professionals and patient associations, has established recommendations to support the replacement of the drug. “Do not interrupt your treatment for yourself, recommends the health agency. Brutal judgment can represent a greater risk than exposure to nitrosamine impurities likely to be present. There is an increased risk of withdrawal syndrome, exposing to nausea, vomiting, abdominal pain, diarrhea, sleep disorders, anxiety, nervousness, headache, discomfort. “
The drug affected by the recall is Ludiomil® (Maprotiline), an antidepressant from the family of monoamine reuptake inhibitors, often prescribed in the second or third intention in depressive episodes. The lots were distributed until March 31, 2025, but some patients may still have it at home. These are Ludiomil® 25 mg and Lot F0018 Ludiomil® 75 mg lots. “”Consult your doctor, he can prescribe another antidepressant alternative “.
The ANSM asks doctors to favor amitriptyline (laroxyl® and generic), an antidepressant from the same family as ludiomil and widely used in France, as an alternative. They can also prescribe mirtazapine. It does not belong to the same class as Maprotiline but it has been identified as a possible alternative due to comparable sedative action and a better tolerance profile. Prescribing doctors must contact patients “Without delay the date of the next order renewal”. Do not hesitate, as a patient, to call the doctor who prescribed the Ludiomil®.
