Serious Hypersensitivity Reactions and Acute Pancreatitis Reported with Onglyza® (saxagliptin); Label Update for Onglyza® (saxagliptin) tablets

Bristol-Myers Squibb and AstraZeneca would like to update healthcare professionals on worldwide post-marketing reports of serious hypersensitivity reactions and acute pancreatitis associated with the use of saxagliptin. A total of 56 cases of pancreatitis, 70 cases of angioedema and 11 cases of anaphylactic responses were received spontaneously from worldwide sources. Reports on hypersensitivity included anaphylaxis, angioedema, and exfoliative skin conditions The local package insert for Onglyza® has been strengthened to include this safety information. Healthcare professionals are advised to counsel their patients that acute pancreatitis and serious hypersensitivity have been reported with the use of saxagliptin and to look out for signs and symptoms suggestive of these conditions. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for more details on these reports and the full prescribing information for Onglyza® that is available at the HSA website.
Healthcare professional
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.