PRAC starts review of depression and anxiety medicine Deanxit (flupentixol/melitracen)

PRAC has started a review of Deanxit, a fixed-dose combination medicine for treating depression and anxiety, following reports of serious neurological and psychiatric side effects in patients taking the medicine.

The reports concern cases involving movement disorders, such as tremors, stiffness, restlessness and involuntary movements, and memory and thinking problems. In some cases, symptoms persisted after treatment was stopped. 

More information is available in EMA’s start of referral communication.

PRAC reviews increased reporting of allergic reactions with specific batches of human normal immunoglobulin medicines

PRAC has started a review of a safety signal concerning increased reporting of hypersensitivity (allergic) reactions associated with specific batches of human normal immunoglobulin medicines.

Human normal immunoglobulins are used to help prevent infections in people who do not…