PharmacovigilanceOfficial

PRAC starts EU-wide review of depression drug Deanxit over neurological and psychiatric safety concerns

🇨🇿 SÚKL · Mon 02 Nov 2026

The EMA's safety committee will weigh the benefits and risks of the flupentixol/melitracen combination after Belgium raised concerns about severe, long-lasting and possibly irreversible side effects.

The Czech State Institute for Drug Control (SÚKL) has announced that the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has begun a re-evaluation of Deanxit, a fixed-dose combination of flupentixol and melitracen used to treat depression and anxiety. SÚKL published the notice on 2 November 2026.

The review follows concerns about serious neurological and psychiatric adverse reactions. Reported suspected cases include movement disorders such as tremor, stiffness, restlessness and involuntary movements, as well as problems with memory and thinking. In some cases the symptoms reportedly continued after treatment had stopped.

SÚKL notes that neurological and psychiatric reactions are already described in the product information. The Belgian medicines agency started the procedure because of the severity and duration of these effects, long-term functional impairment and the possibility that some may be irreversible. Belgium has also questioned the benefits of combining the two active substances in Deanxit.

PRAC will assess all available data on the benefits and risks of Deanxit and consider whether the marketing authorisation should be maintained, varied, suspended or revoked. Deanxit is a tablet containing 0.5 mg flupentixol and 10 mg melitracen. Its use varies across EU countries and includes depression, anxiety, asthenia and psychological problems accompanied by physical symptoms.

Deanxit was first authorised in the EU in Austria in 1971 and is currently authorised in Austria, Belgium, Bulgaria, Cyprus, Luxembourg, Malta and Spain. No product containing the combination is registered in the Czech Republic. Medicines containing flupentixol alone, mainly used for schizophrenia and other psychoses, are not part of the review. Melitracen is no longer marketed as a single-ingredient product in any EU country.

What it means for your team

  • Marketing authorisation holders for Deanxit in the seven countries where it is authorised should prepare for PRAC requests for data on benefits, risks and the rationale for the fixed combination.
  • PV teams may want to review case data on movement disorders and cognitive effects, especially cases where symptoms persisted after discontinuation.
  • Single-ingredient flupentixol products are outside the scope of the review, and there is no direct national impact in the Czech Republic.
  • Possible outcomes range from no change to variation, suspension or revocation of the authorisation, so supply and labelling planning may be affected in the countries concerned.

Official source: SÚKL ↗

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

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