The Laboratory Center Pharmaceutical Specialties (CSP), in connection with the National Medicines Safety Agency (ANSM), is recalling all Ludiomil lots (Maprotiline) 25 and 75 mg, distributed until March 31, 2025, due to nitrosamine type impurities at rates higher than the European authorities (18 NG/D). Consequently, the antidepressant will be out of total stock until “At best at the end of 2026”announces the health authority, while the AMDIPHARM laboratory, holder of the marketing authorization (CSP is the operator), “Work on a change in its manufacturing process to reduce the level of nitrosamines in your medication”.
This antidepressant is indicated in characterized depressive episodes, often in the second or third intention. Currently 5,000 patients, mostly over the age of 60, are treated by this drug in France.
To deal with the unavailability of treatment, ANSM, “In connection with representatives of health professionals and patient associations” Publish the behaviors to be taken for the management of the patients concerned. She recommends “As much as possible” that prescribing doctors meet patients “Without delay the date of the next prescription renewal in order to ensure continuity of treatment and follow -up adapted to the transition period”.
LaroXyl or Norset as an alternative
The replacement with amitriptyline (laroxyl and generic), an antidepressant of the same family as the ludiomil (inhibitor of the reuptake of the monoamines, mainly of the noradrenaline), must be privileged. Patients under treatment by Ludiomil can transition to this new molecule in two modalities.
The medication can be replaced in one go: stopping Maprotiline on J0 and Introduction to D1 of the therapeutic dose amitriptyline (possible because of their great similarity). The ANSM nevertheless recommends a slippery transition, over several days, “For patients who still have mapprotiline, or if pharmacy stocks allow it” : 25 % reduction in the dose of mapprotiline and the introduction of the low -dose amitriptyline on the first day and continue the replacement levels every three to four days. And to remember that “The maintenance dose of amitriptyline is the lowest effective dose” With a maximum of 150 mg per day divided into two sockets.
Another alternative proposed by the ANSM: MIrtazapine (Norset and Generics), not belonging to the same class as Maprotiline but having “A comparable sedative action and a better tolerance profile”. In this context, the replacement of treatment is necessarily progressive, over several days and up to four weeks. Every three to four days or every week, the dose of maprotiline will have to be reduced by around 25 %. MIRTAZAPINE, introduced at 15 mg on the first day, will be increased gradually if necessary and if good tolerance, the effective daily dose being usually between 15 and 45 mg.