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Strontium Ranelate Restrictions Recommended in EU

The product information for strontium ranelate (Protos) has been updated following European Medicines Agency reports that it may increase the risk of serious heart problems, including myocardial infarction.

These findings came from an analysis by the EMA of pooled data from randomised, placebo-controlled clinical studies, performed as part of a routine safety assessment.

The TGA-approved indication is now 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.

New contraindications have also been added to include people with a history of, or currently experiencing, a range of heart or circulatory problems.


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