Protos set for suspension in Europe
Following an in-depth review the recommendation reflects a series of ongoing investigations into the drug’s benefit-risk profile. In April last year, the product information for the drug, which is marketed as Protelos and Osseor in the EU, was updated following reports that it may increase the risk of serious heart problems, including myocardial infarction.
The findings came from an analysis by the European Medicines Agency of pooled data from randomised, placebo-controlled clinical studies, performed as part of a routine safety assessment, and were of particular concern in view of earlier findings of increased incidence of venous thromboembolism in people taking strontium ranelate.
In Australia, the current TGA-approved indication for the drug is for treatment of severe established osteoporosis in men at increased risk of fracture and for treatment of severe established osteoporosis in postmenopausal women who are at high risk of fracture. Current