The Medicines Agency warns against the unauthorized use of mianserin to combat sleep disorders. Taking it exposes patients to potentially serious side effects.
Are you ready to do anything to get some sleep? Be careful with the medications you take, reminds the National Agency for the Safety of Medicines and Health Products (ANSM) in a press release dated September 14. This time it alerts precisely on mianserin. Of the non-compliant uses medications based on mianserin have been observed, particularly in the management of sleep disorders among those over 65. The Agency recalls that this psychotropic molecule is only authorized in France for patients suffering from major depressive episodes and that it has not received marketing authorization (MA) to treat sleep disorders.
By taking the medicine outside of its marketing authorization, patients are exposed to potentially serious side effects such as :
- exceptional cases agranulocytosis (blood abnormality). This is why a blood count check is recommended, particularly when the patient presents with fever, sore throat or other signs of infection,
- side effects type of drowsiness very common and likely to have significant consequences, particularly in elderly patients,
- of the hepatitis,
- of the convulsions,
- risks ofappearance of suicidal-type behaviors in depressed patients or in patients with a history of suicide-like behavior.
The Health Agency also insists that a severe liver damage is a contraindication taking medications containing mianserin. Several laboratories market antidepressants based on mianserin: Arrow, Biogaran, Cristers, EG, Mylan, Qualimed, Ratiopharm, RPG, Sandoz, Teva, Zentiva.