EMA Opens Review of Deanxit and Related Medicines

Deanxit and other medicines combining flupentixol with melitracen are under European Medicines Agency review following reports of serious neurological and psychiatric effects among people taking Deanxit. The assessment concerns nationally authorised combination products, not medicines containing flupentixol alone, and has not reached a final outcome.

According to EMA, reported symptoms include involuntary movements, tremors, restlessness and stiffness, alongside difficulties with thinking and memory. Some reports describe symptoms persisting after treatment ended. These cases are being assessed and do not constitute a final finding that the medicine caused the effects.

EMA says Deanxit’s product information already includes neurological and psychiatric effects. According to the agency, Belgium’s medicines agency requested the review because of concerns about how severe and lasting the reported effects were, prolonged disability and whether some effects might be irreversible. The Belgian agency also questioned whether combining the two ingredients provides a benefit.

The referral record gives 29 October 2026 as the procedure’s start date. Elsewhere in that record, EMA says the review began on 16 October following the Belgian agency’s request. It is an Article 31 referral, a procedure EMA describes as addressing concerns about medicine quality, safety or efficacy that involve European Union interests.

Deanxit has national authorisations in Spain, Malta, Luxembourg, Cyprus, Bulgaria, Belgium and Austria, according to EMA. The conditions for which it is approved vary between countries. They include anxiety, depression, weakness known as asthenia, and psychological conditions accompanied by physical symptoms.

EMA gives the contents of each Deanxit tablet as 10 mg of melitracen and 0.5 mg of flupentixol. Its explanation of the ingredients’ actions describes melitracen as reducing serotonin and noradrenaline reuptake, while flupentixol blocks dopamine receptors. That description does not establish whether the fixed combination’s benefits outweigh its risks, which is the subject of the review.

Under the process described by EMA, PRAC will examine the available evidence on benefits and risks before recommending an outcome. The recommendation will then go to the CMDh for a position because the medicines have national authorisations. The options being considered are to leave those authorisations unchanged, amend them, suspend them or revoke them. None of those options represents a final decision at this stage.

Austria granted Deanxit its first authorisation in 1971, according to EMA. The agency also says melitracen was once available on its own as a depression treatment, but that single-ingredient product is no longer available in the EU.

* This article is based on publicly available information at the time of writing.