Restricted indication and monitoring recommendations for Protos® (strontium ranelate) following benefit-risk assessment by the European Medicine Agency (EMA)

Servier would like to inform healthcare professionals of the restricted indication and monitoring recommendations in the local package insert of Protos^® to mitigate the risk of cardiovascular disorders, including myocardial infarction, following the benefit-risk assessment of strontium ranelate by the European Medicine Agency. The use of Protos^® is now restricted to the treatment of severe osteoporosis in postmenopausal women at high risk of fracture, for whom treatment with other medicinal products for osteoporosis is not possible due to, for example, contraindications or intolerance. Prescribers are also advised to evaluate patients with respect to cardiovascular risk before starting treatment, monitor patients’ cardiovascular risk every 6 -12 months and stop treatment if the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled. Please refer to HSA website for the latest approved package inserts.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

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.