Onglyza (BMS/AstraZeneca)alerts for hypersensitivity reactions

BMS and AstraZeneca have alerted physicians in both the EU and US to reports of serious hypersensitivity reactions to Onglyza (saxagliptin). Labelling changes have been made following reports, which include 56 cases of pancreatitis, 70 cases of angioedema and 11 cases of anaphylactic responses received spontaneously from worldwide sources. Reports on hypersensitivity included anaphylaxis, angioedema and exfoliative skin conditions. Saxagliptin is now contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock or angioedema to saxagliptin or any other DPP-IV inhibitor. Patients need also to be informed of the characteristic symptom of acute pancreatitis, ie, persistent severe abdominal pain, and the drug should be discontinued if pancreatitis is suspected. Pancreatitis has been recognised as an adverse event for other DPP-IV inhibitors including Januvia (sitagliptin) from Merck Inc., which had its label updated following cases of pancreatitis in 2009.