The National Medicines Safety Agency (ANSM) announced on July 29, 2025 the recall of several batch of the drug Ludiomil, an antidepressant used in around 5,000 patients in France. In question: the presence of impurities of the nitrosamine type, at levels higher than the limits authorized by European standards.
These impurities are potentially carcinogenic substances for humans. Consequently, the ANSM has decided to withdraw these prizes from the market, and the Ludiomil will no longer be available to “new order.
What are nitrosamines?
Nitrosamines are chemical compounds that can be found in certain drugs, formed during manufacture, of a recycling of solvents or by degradation of the active molecule. According to European health authorities, they are classified among the substances probably carcinogenic for humans. Their presence is therefore strictly framed and tolerated only at very low dose.
Who is affected by this withdrawal?
The Ludiomil, whose active substance is Maprotiline, is an antidepressant generally prescribed in the second or third intention, often in patients over 60 years of age. Its production had already been suspended last March, pending results on the presence of nitrosamines. The AMDIPHARM laboratory plans to modify its manufacturing process, with a possible return of the drug at the end of 2026.
What are the alternative treatments available?
For patients currently under Ludiomil, substitution treatments are possible. Doctors can offer:
- Amitriptyline (marketed in particular under the name Laroxyl);
- Or mirtazapine.
The change of treatment can be done gradually or immediately, depending on the situation of each patient, and must be supervised by a healthcare professional.
I take Ludiomil: What should I do?
The ANSM website insists: “Do not interrupt your treatment without medical advice. “
A brutal stop from Ludiomil can cause withdrawal syndrome, with side effects such as:
- Nausea, vomiting, abdominal pain, diarrhea;
- Anxiety, nervousness, sleep disturbances;
- Headache (headache), discomfort.
It is essential to consult your doctor to discuss alternative treatment. This will prescribe, if necessary, a new antidepressant according to your state of health and your tolerance.
Anyway, scrupulously respect the new prescription and the protocol set up by your healthcare professional.