PharmacovigilanceOfficial

EMA safety committee starts review of depression and anxiety medicine Deanxit

🇪🇺 EMA · Fri 30 Oct 2026

PRAC is assessing the flupentixol/melitracen combination after the Belgian agency raised concerns over severe, lasting movement, memory and thinking side effects and the rationale for combining the two substances.

The European Medicines Agency's safety committee, PRAC, has begun an Article 31 review of Deanxit, a fixed-dose combination of flupentixol and melitracen used for depression and anxiety. The Belgian medicines agency requested the review. EMA published the notice on 30 October 2026.

The trigger was reports of serious neurological and psychiatric side effects. These include movement disorders such as tremors, stiffness, restlessness and involuntary movements, as well as memory and thinking problems. In some cases, symptoms continued after treatment stopped. Such effects are already listed in the product information, but the Belgian agency is concerned about their severity and duration, prolonged disability and the possibility that some may be irreversible. It has also questioned the benefit of combining the two active substances.

PRAC will evaluate all available data on Deanxit's benefits and risks. It will consider whether the marketing authorisations should be maintained, varied, suspended or revoked. Deanxit tablets contain 0.5 mg of flupentixol and 10 mg of melitracen. Uses differ between EU countries but include depression, anxiety, asthenia and psychological conditions with physical symptoms. Medicines containing only flupentixol, used mainly for schizophrenia and other psychoses, are not covered.

Deanxit is authorised only at national level, in Austria, Belgium, Bulgaria, Cyprus, Luxembourg, Malta and Spain. It was first authorised in Austria in 1971. Because of this, PRAC's recommendations will go to the CMDh, the group representing EU Member States plus Iceland, Liechtenstein and Norway, which will adopt a position. EMA's text says the review was initiated on 16 October 2026, while the procedure page lists a start date of 29 October 2026. EMA has published the notification, Annex I, a PRAC list of questions and a timetable, but the summary does not give the dates in the timetable.

What it means for your team

  • Marketing authorisation holders for Deanxit in the seven countries concerned should expect to answer the PRAC list of questions within the published timetable.
  • Pharmacovigilance teams may want to review case data on persistent movement disorders and cognitive effects after discontinuation, as these are the focus of the review.
  • Possible outcomes range from no change to variation, suspension or revocation, so market-access and supply planning for the combination could be affected once the CMDh adopts its position.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

More Pharmacovigilance All →