EMA Opens Deanxit Safety Review Over Movement and Memory Side Effects
November 2, 2026
A Deanxit safety review has started at EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), after adverse reaction reports of serious neurological and psychiatric side effects in patients taking the fixed-dose depression and anxiety medicine. The reports describe movement disorders (tremors, stiffness, restlessness and involuntary movements) and problems with memory and thinking. In some patients the symptoms persisted after they stopped treatment.
Belgium’s concerns behind the Deanxit safety review
The product information already lists neurological and psychiatric side effects. The Belgian medicines agency asked for the review anyway, citing how severe and long-lasting the effects were, prolonged disability, and the possibility that some may be irreversible. It also questioned the benefit of combining the two active substances. The procedure began on 16 October 2026 under Article 31 of Directive 2001/83/EC, and EMA announced it on 30 October 2026 (EMA/244566/2026).
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