Update on the risk management plan for strontium ranelate (Protos®) to mitigate the risks of serious skin reactions

The Health Sciences Authority (HSA) would like to update healthcare professionals on the risk management plan (RMP) for strontium ranelate (Protos®, Servier) to mitigate the higher than reported risks of serious skin reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) in the local population. The RMP that has been finalised for strontium ranelate includes strengthening of the local package insert about the higher risk of serious skin reactions in the Asian population, the development of a Patient Medication Guide to alert patients to the signs and symptoms of serious skin reactions and the collection of data on patients newly initiated on strontium ranelate through a Patient Care Program. Please refer to the letter for the details.

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.