Oct 30 (Reuters) – The European Medicines Agency’s risk-monitoring committee said on Friday it had begun reviewing Deanxit, a depression and anxiety medicine by Danish drugmaker H Lundbeck, following reports of serious neurological and psychiatric side effects.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will evaluate the reports and other available data before deciding whether to retain, amend, suspend or revoke the drug’s marketing authorisation. The review is expected to conclude by March 2027.
Here are more details:
• The committee said the review was triggered after Belgium’s medicines agency received 23 spontaneous reports of serious side effects between 2024 and 2026
• Deanxit, an oral tablet first approved in Austria in 1971, is a combination of an antipsychotic called flupentixol and an antidepressant, melitracen
• PRAC said the reports involved cases of movement disorders as well as memory and cognitive problems, adding that in some instances symptoms persisted even after patients stopped taking the medication
• H Lundbeck declined to comment
• Belgium’s medicines agency wants the EMA to review whether taking flupentixol and melitracen individually is more effective than Deanxit’s combination
• The Belgian agency also raised concerns about the long-term use of Deanxit
• Flupentixol has been linked to potentially irreversible serious side effects, with some patients continuing with the medication for up to 25 years despite nerve-related adverse effects
(Reporting by Vera Dvorakova and Bhanvi Satija; Editing by Mrigank Dhaniwala and Diti Pujara)
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