The European Medicines Agency has launched a review of Deanxit, a depression and anxiety drug manufactured by H Lundbeck, following 23 reports of serious neurological and psychiatric side effects submitted to Belgium's medicines agency between 2024 and 2026. Symptoms including movement disorders and memory problems persisted in some patients even after treatment stopped. Regulators will determine by March 2027 whether to retain, modify, or revoke the drug's authorization.
EMA safety review of Deanxit
- ▪Reports submitted to the European Medicines Agency regarding Deanxit included cases of movement disorders, with symptoms persisting in some patients even after stopping the medication, and memory, thinking, and cognitive problems.
- ▪The European Medicines Agency's Pharmacovigilance Risk Assessment Committee began reviewing Danish drugmaker H Lundbeck's depression and anxiety medicine Deanxit on October 30, 2026, following reports of serious neurological and psychiatric side effects.
- ▪The European Medicines Agency's Pharmacovigilance Risk Assessment Committee will evaluate Deanxit data to decide whether to retain, amend, suspend, or revoke the drug's marketing authorization, with the review expected to conclude by March.
- ▪Danish drugmaker H Lundbeck declined to comment on the European Medicines Agency's safety review of Deanxit.
Concerns raised by Belgium's Medicines Agency
- ▪Belgium's medicines agency requested the European Medicines Agency review whether taking flupentixol and melitracen individually is more effective than Deanxit's combination formulation.
- ▪Belgium's medicines agency raised concerns about the long-term use of Deanxit, noting that flupentixol has been linked to potentially irreversible serious side effects.
- ▪The European Medicines Agency's safety review of Deanxit was triggered after Belgium's medicines agency received 23 spontaneous reports of serious side effects between 2024 and 2026.
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