ADR that result in revision of patient information
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| The United Kingdom: The association of saxagliptin (Onglyza) with serious hypersensitivity reactions and acute pancreatitis |
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Bristol-Myers Squibb, AstraZeneca and the MHRA inform healthcare professionals of important new safety information regarding saxagliptin use and the associated risk of serious hypersensitivity reactions and acute pancreatitis. Cases of serious hypersensitivity reactions, including angioedema and anaphylactic reactions and acute pancreatitis have been reported with the use of saxagliptin (Onglyza). Because of these safety concerns, the following recommendations for saxagliptin use have been made: Regarding hypersensitivity reactions, saxagliptin is now contra-indicated in patients with a history of serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, or angioedema, to saxagliptin, any dipeptidyl peptidase 4 (DPP-4) inhibitor. If a serious hypersensitivity reaction to saxagliptin is suspected, this treatment should be discontinued. Regarding pancreatitis, patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, saxagliptin should be discontinued. The product information for Onglyza (saxagliptin) has been updated with information on hypersensitivity and pancreatitis
http://www.mhra.gov.uk/home/groups/comms-ic/documents/drugsafetymessage/con146917.pdf
In Hong Kong, Onglyza Tablet 2.5mg (HK-60783) and 5mg (HK-59907) are registered by Bristol-Myers Squibb Pharma (HK) Ltd and are prescription-only medicines. The news has been released by the Singapore HSA and was posted on the website of the Drug Office on 8 March 2012. A letter for healthcare professionals was issued on the same day. The matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, March 31, 2012
Issued at HKT 12:30 |
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