The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has started a review of Deanxit, a fixed dose combination of flupentixol and melitracen used for depression and anxiety, following reports of serious neurological and psychiatric side effects. The reports cover movement disorders such as tremors, stiffness, restlessness and involuntary movements, and problems with memory and thinking. In some cases the symptoms persisted after treatment was stopped, the agency said.
PRAC has also started a review of increased reporting of hypersensitivity, or allergic, reactions associated with specific batches of human normal immunoglobulin medicines. These products are used to prevent infections in people who do not have enough antibodies, including some immune disorders and blood cancers, and to treat conditions in which the immune system attacks the body own tissues. Hypersensitivity is a known side effect and the product information already warns that serious reactions can occur even in patients who previously tolerated treatment, but reports indicate reactions may be occurring more frequently than expected with specific batches.
The reported cases range from rash and itching to anaphylaxis and angioedema. Clusters have already led to recalls of specific batches of Flebogamma DIF, Yimmugo and Gamunex in certain EU member states, and those batches have been withdrawn from the market as a precaution. The cause of the clusters has not been established, and it is not yet clear whether other immunoglobulin medicines could be affected.
The scope is therefore class wide. The review will cover all human normal immunoglobulin medicines however they are given, intravenously, under the skin or into muscle. PRAC will request data from the marketing companies and assess it against the available evidence to investigate causes and decide whether further measures are needed. Healthcare professionals were reminded to follow the existing warnings and to monitor patients during treatment.
Neither review has reached a recommendation. For Deanxit the question is whether the reported neurological and psychiatric effects change the benefit risk balance of a widely used combination product. For immunoglobulins the question is narrower and more operational: whether a batch specific manufacturing or handling issue explains the clusters, or whether the signal extends across suppliers, which would matter for a product class that hospitals cannot easily substitute.