Other safety alerts
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| Singapore: Increased Risk of Glibenclamide-Induced Severe and Protracted Hypoglycaemia in the Elderly and Renal Impaired |
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Health Sciences Authority (HAS) had conducted a benefit-risk assessment of glibenclamide in consultation with endocrinologists and its Product Vigilance Advisory Committee, prompted by reports of a disproportionately higher number of hospitalisation cases due to hypoglycaemia associated with glibenclamide as compared to other sulfonylureas. Based on the review, which found an increased risk of severe and protracted hypoglycaemia associated with glibenclamide, HSA would like to advise healthcare professionals that the use of glibenclamide should be avoided in the following patients: those above 60 years old, those with estimated glomerular filtration rate (eGFR) less than 60ml/min/1.73m2, or those with serum creatinine (SrCr) above the upper limit of normal.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, there are 30 registered pharmaceutical products containing glibenclamide. All the products are prescription only medicines. So far, the Department of Health (DH) has not received any adverse reaction report in connection with the drug. DH will contact HSA for details of the review and keep vigilant on any safety updates of the drug and actions taken by other overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Thursday, December 05, 2013
Issued at HKT 13:00
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