The TGA have commenced a review of the risks associated with using the osteoporosis medicine, strontium ranelate (Protos®). This review follows recent extension of the contraindications and precautions relating to venous thromboembolic events and serious skin hypersensitivity reactions.

The European Medicines Agency, however, are considering withdrawing the product following a routine risk-benefit assessment that identified an increased risk of heart attack, but not of mortality.

These developments act as a reminder of the importance in reporting adverse reactions to medicines. The Database of Adverse Event Notifications show that 370 reports have been made in Australia, since 2006, including 20 pulmonary emboli, 16 deep vein thromboses, 12 cardiac events, and several hypersensitivity reactions.

Strontium ranelate should not be prescribed if the patient has renal impairment, any history (or risk) of a venous thromboembolic event, including temporary immobilisation during post-surgical recovery or prolonged bed rest. Additionally, cardiovascular risk should be evaluated.

Please review full product information before prescribing.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

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