The product information for Protos® (strontium ranelate) has again been updated, this time including a black box warning, to emphasise the contraindications and precautions, and to recommend regular monitoring following a TGA review as previously reported by HPS Pharmacies.
Protos® should not be used when it may exacerbate the risk of cardiac or thromboembolic events, including the risk from temporary immobility, such as during hospitalisation.
Prescribers should also be alert for signs of rare but severe skin reactions, such as drug rash with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis.
All patients should be fully informed of the risk of cardiovascular events and venous thrombosis, and should be monitored at least every six months.
Strontium ranelate remains an important medicine to restore bone density in patients with severe osteoporosis, but only when other medications are considered unsuitable through contraindications or intolerance, and should be initiated by medical practitioners with experience in treating osteoporosis.
Please review full product information before prescribing.