Important update regarding imiglucerase (Cerezyme®)

Genzyme informs healthcare professionals of trace amount of 2,4-dichlorobenzoic acid (2,4-DCBA) in some vials of Cerezyme® filled at the Waterford, Ireland facility. Investigations and root cause analysis identified the source to be a leachable from the peroxide-cured silicone tubing used at the Waterford filling line. Through investigations and safety database review, Genzyme concluded that the likelihood of 2,4-DCBA being present in Cerezyme® is extremely low and risk to patient safety is low. As part of Genzyme's corrective action plan, the peroxide-cured tubing was replaced with new tubing that does not contain 2,4-DCBA on 25 Feb 2010. While prior lots of Cerezyme® shipped to Singapore may have traces of 2,4-DCBA, future patient exposure to 2,4-DCBA has been eliminated by replacing lots of Cerezyme® with lots manufactured using the new tubing.

 
 
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.