Protos under TGA risk review
It comes just weeks before the European Medicines Agency (EMA) is expected to announce suspension of the drug.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspending it last month following a series of investigations into its risk-benefit profile.
It found there were four or more cases of both cardiac events, including myocardial infarction, and thrombosis with Protos for every 1000 patient-years, compared with placebo. Seizures, liver inflammation and skin reactions were also reported.
The TGA warned