TGA warns on Protos restrictions

Australia has followed the European lead on the cardiovascular risks of strontium ranelate (Protos), with the TGA adding a black box warning and advising that the drug should only be used as a last resort for severe osteoporosis.

In the latest Medicines Safety Update, the TGA says that following a risk benefit review it now advises that strontium ranelate “only be used if all other treatments are deemed unsuitable, either due to contraindications or intolerance”.  

A black box warning has been added to the packaging and the Product Information now includes an update to the