Epilim® (valproate) – New restrictions on use

Sanofi-Aventis would like to inform healthcare professionals about the new restrictions that have been put in place to prevent valproate exposure during pregnancy. These new restrictions include contraindications for the use of valproate during pregnancy and the implementation of a pregnancy prevention programme. Healthcare professionals are reminded that children exposed in utero to valproate are at a high risk of serious developmental disorders (up to 30-40%) and of congenital malformations (approximately 10%) and valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated. To further strengthen the measures to prevent valproate exposure during pregnancy, valproate is now contraindicated in pregnancy for the treatment of bipolar disorder. For the treatment of epilepsy, valproate is contraindicated in pregnancy unless there are no suitable alternatives. For women of childbearing potential, valproate should only be used in exceptional cases and the conditions of the pregnancy prevention programme must be fulfilled. A set of educational materials comprising a Guide for Healthcare Professionals, a Patient Guide and a Patient Card, has also been developed by Sanofi-Aventis to inform healthcare professionals and patients/caregivers on the risks of valproate and the conditions for use. Sanofi-Aventis will be updating the package inserts of all Epilim® products to reflect the new restrictions and conditions for use of valproate. Please refer to the letter for 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.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

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

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