EMA Initiates Formal Safety Review of Fixed-Dose CNS Combination Drug Deanxit

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has begun a formal safety review of Deanxit, a fixed-dose combination of the antipsychotic flupentixol and antidepressant melitracen. This review follows reports of serious neurological and psychiatric adverse events, signaling increased scrutiny on fixed-dose central nervous system (CNS) combination products.