EMA Reviews Depression, Anxiety Drug Over Adverse Effects

Deanxit (flupentixol-melitracen), a fixed-dose combination medicine used to treat depression and anxiety, is under review following reports of serious neurologic and psychiatric adverse effects.The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started the review after reports of movement disorders such as involuntary movements, stiffness, tremors, and restlessness, as well as memory and thinking problems. In some cases, symptoms reportedly persisted after treatment was stopped.Belgium’s medicines regulatory authority requested the review, citing concerns about the severity and duration of these reactions, the potential for prolonged disability, and whether some effects could be irreversible. It also questioned the benefits of combining flupentixol and melitracen in a single product.About the Medicine Deanxit tablets contain 0.5 mg of flupentixol and 10 mg of melitracen. Its uses vary by country but include the treatment of depression, anxiety, asthenia (weakness), and psychological conditions with physical symptoms.Flupentixol affects dopamine signaling and is also available as a single-ingredient medicine, used mainly to treat schizophrenia and other psychotic disorders. However, standalone flupentixol products are not included in the current review.Melitracen affects serotonin and noradrenaline signaling. It was previously available as a single-ingredient treatment for depression, but single-ingredient melitracen is no longer available in the European Union.First authorized in Austria in 1971, Deanxit currently also holds marketing authorizations in Belgium, Bulgaria, Cyprus, Luxembourg, Malta, and Spain.Next Steps Belgium initiated the review on 16 October 2026. PRAC will assess all available data on Deanxit’s benefits and risks and decide whether the marketing authorizations should be maintained, varied, suspended, or revoked.PRAC will send its recommendations to the Co-ordination Group for Mutual Recognition and Decentralized Procedures–Human (CMDh). The CMDh represents EU member states plus Iceland, Liechtenstein, and Norway and harmonizes safety standards for nationally authorized medicines across the EU. It will adopt a position based on PRAC’s recommendations.This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.