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EU drug safety panel starts review of Deanxit after side-effect reports
The European Medicines Agency's PRAC said Friday it has begun a review of the depression and anxiety medicine Deanxit after reports of serious neurological and psychiatric side effects.
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee said it has started a review of Deanxit, a fixed-dose combination medicine used to treat depression and anxiety, after reports of serious neurological and psychiatric side effects in patients taking it2.
Deanxit combines flupentixol and melitracen, the agency said in highlights from its Oct. 26-29 meeting2. Reuters separately reported that the EMA had begun the review after side-effect reports1.
The reports concern movement disorders, including tremors, stiffness, restlessness and involuntary movements, as well as memory and thinking problems, according to the EMA2. In some cases, symptoms persisted after treatment was stopped2.
The agency said more information is available in a start-of-referral communication2. The outcome of the review was not announced2.
