Protos under TGA review for adverse reaction

The Australian review 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 the drug earlier this month following a series of investigations into its risk-benefit profile. 

In April 2013, the PRAC advised restrictions on the use of the product after a routine safety assessment found that it may increase the risk of serious coronary problems, including myocardial infarction. 

Following a further review of the data, it reported that there were four or more cases of cardiac events and thromboembolism with strontium ranelate for every 1000 patient-years, compared with placebo.

Protos was also associated with a number of other risks, including serious skin reactions, disturbance in consciousness, seizures, liver inflammation and reduced number of red blood cells.