EU Committee Launches Safety Review of Deanxit
The Pharmacovigilance Risk Assessment Committee is investigating reports of serious neurological and psychiatric side effects.
Updated on Oct. 30, 2026 in Alzheimer’s
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The Pharmacovigilance Risk Assessment Committee has initiated a safety review of the medicine Deanxit following concerns regarding severe side effects. The review stems from reports of neurological and psychiatric issues, including movement disorders and cognitive impairment, in patients taking the drug.
Why it matters
The review was triggered by the Belgian medicines agency to determine if the benefits of the fixed-dose combination medication still outweigh its identified risks. Officials are specifically investigating the severity, duration, and potential irreversibility of symptoms reported by patients.
Deanxit tablets contain a fixed-dose combination of 0.5 mg flupentixol and 10 mg melitracen. This review evaluates the clinical benefits and safety profile of these active substances for patients across authorized markets.
The players
Pharmacovigilance Risk Assessment Committee
This body evaluates the safety of human medicines and manages the risk of side effects throughout the drug's lifecycle.
Belgian medicines agency
This national authority is responsible for the oversight of medicinal products and triggered the current review under European Union directives.
The details
Patients have reported experiencing serious movement disorders, such as tremors, stiffness, and restlessness, alongside memory and thinking difficulties. Some of these neurological and psychiatric symptoms were observed to persist even after individuals ceased treatment with the medication.
Timeline
1971: Deanxit was first authorized in Austria.
October 16, 2026: The safety review of Deanxit was initiated.
Health Landscape
This investigation follows the standard procedural framework established by Article 31 of Directive 2001/83/EC for addressing safety concerns within the European Union. It reflects the ongoing efforts of regulatory bodies to reassess the long-term benefit-risk balance of legacy medications.
Patients currently prescribed Deanxit should consult with their healthcare providers regarding any symptoms or concerns about their treatment. No changes should be made to prescribed regimens without professional medical guidance while the regulatory review remains ongoing.
The takeaway
Patients who have been taking the medication are encouraged to monitor their neurological health and discuss any new symptoms with their doctor. Medical professionals should remain informed on the safety review's progress as regulators assess if current usage remains appropriate.
Further reading
For more information on similar pharmaceutical evaluations, visit the Alzheimer’s section.
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