Proluton Depot Injection 250mg/ml: Update on benefit-risk balance and discontinuation in supply

A Dear Healthcare Professional Letter has been issued by Bayer (South East Asia) Pte Ltd to inform healthcare professionals of the assessment outcome for hydroxyprogesterone (17-OHPC)-containing medicinal products by the Pharmacovigilance Risk Assessment Committee in the European Union. The overall benefit-risk balance of 17-OHPC-containing medicines is no longer considered positive. This is in consideration of results from an epidemiological study suggesting an increased cancer risk in offspring exposed to 17-OHPC in utero and evidence from a clinical trial showing lack of efficacy of 17-OHPC in prevention of pre-term birth and limited evidence of efficacy in other obstetrical and gynaecological indications. Bayer will discontinue the supply of Proluton Depot, with current available batch expiring in January 2026. Healthcare professionals are advised to exercise clinical discretion before initiating patients on Proluton and plan for alternative treatments if necessary. Please refer to the letter for 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.