Increase in local reports of serious skin reactions related to strontium ranelate (Protos®)

The Health Sciences Authority (HSA) would like to alert healthcare professionals on the increase in the number of local reports of serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS) suspected to be associated with strontium ranelate (Protos^®) leading to a benefit-risk review of the drug. While the review demonstrated a favourable benefit-risk ratio, a risk management plan is proposed to mitigate the risks of serious skin reactions related to strontium. HSA is still working through the details of the risk management plan and will update healthcare professionals once it is finalised. Healthcare professionals are strongly advised to weigh the benefit versus risk of initiating strontium ranelate for the individual patient and to monitor patients closely for the possibility of serious skin reactions. Patients should also be educated on early recognition of these reactions.

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 ↗ (opens in new tab) 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.