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.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.