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.

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.