Important new recommendations for the use of Protos® (strontium ranelate) following new data showing an increased risk of non-fatal myocardial infarction

Servier would like to inform healthcare professionals that arising from the recent review of safety data on Protos® (strontium ranelate) by the European Medicines Agency (EMA) which identified an increased risk for serious cardiac disorders, including myocardial infarction with no observed risk in mortality, the use of Protos® is now restricted to the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. In addition, the use of Protos® is contraindicated in patients with established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, and uncontrolled hypertension. Treatment should only be initiated by a physician with experience in the treatment of osteoporosis, and the decision to prescribe Protos® should be based on an assessment of the individual patient's overall risks. Physicians are advised to assess the patient's risks of developing cardiovascular disease before starting treatment and thereafter at regular intervals. Please refer to the letter for more details.

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Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.