The National Agency for the Safety of Medicines and Health Products (ANSM) has warned of the non-compliant use of mianserin, a treatment prescribed to treat depression.
- Mianserin is primarily prescribed to treat depression.
- The National Agency for the Safety of Medicines and Health Products (ANSM) has warned of the non-compliant use of mianserin in patients without depressive disorders.
- Taking mianserin off-label carries a risk of potentially serious side effects, particularly in people over 65 years of age.
Mianserin is a treatment indicated in patients with major depressive episodes. However, reports of non-compliant use of this medicine have been reported to the National Agency for the Safety of Medicines and Health Products (ANSM) during the last years.
The consequences of improper use of mianserin in the elderly
In a statement published on September 14, the ANSM warned against the non-compliant use of mianserin to treat sleep disorders in people aged over 65 and not depressed. This use has not been evaluated and/or validated within the framework of the Marketing Authorization (AMM).
In France, a survey published in 2021 assessed the proper use of mianserin-based specialties in hospital establishments. Of the 102 structures, nearly 11% indicated the use of mianserin-based specialties in sleep disorders. “However, to date, the available data do not justify the use of mianserin outside its indication. This non-compliant use would expose patients to avoidable iatrogenics”warned the ANSM.
What are the potential side effects of mianserin?
Taking mianserin off-label poses many health risks, especially in people over 65 years old. The health agency has notably listed the potential adverse effects linked to this non-compliant use:
- exceptional cases of agranulocytosis;
- adverse effects such as drowsiness that are very common and likely to have significant consequences, particularly in elderly patients;
- hepatitis;
- seizures;
- risks of suicidal-type behavior occurring in depressed patients or in patients with a history of suicide-type behavior.
To prevent these risks of side effects, the ANSM reiterated that it is important to respect the MA indication, the dosage, the warnings and the contraindications (including severe liver damage), especially in elderly patients.
