Other safety alerts
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| Singapore: Forxiga (dapagliflozin): Risk of diabetic ketoacidosis |
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AstraZeneca would like to inform healthcare professionals of the risk of diabetic ketoacidosis (DKA) during treatment with sodium glucose co-transporter 2 (SGLT2) inhibitors, including Forxiga. Serious and sometimes life-threatening cases of DKA in patients treated with SGLT2 inhibitors have been reported, with the majority of them requiring hospitalization. The presentation of DKA in a number of cases was atypical in that glucose levels were only mildly elevated at less than 11 mmol/L (or 200 mg/dL), while DKA typically occurs at glucose levels greater than 14 mmol/L (or 250 mg/dL).
Healthcare professionals are advised to assess the patients, who are taking SGLT2 inhibitors, for ketoacidosis when they present with signs or symptoms of metabolic acidosis in order to prevent delayed diagnosis and patient management.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../forxiga-dapagliflozinriskofdiabeticketoacidosis.html
In Hong Kong, there are two registered pharmaceutical products containing dapagliflozin, namely Forxiga Tablet 5mg (HK-63301) and Forxiga Tablet 10mg (HK-63302). Both products are registered by AstraZeneca Hong Kong Ltd (Astra), and are prescription-only medicines. Related news had been issued by the US FDA, Health Canada, UK MHRA and Taiwan FDA, and was posted on the Drug Office website on 16 May, 23 June, 27 June and 29 June 2015 respectively. On 10 July 2015, Astra notified the Department of Health (DH) that they would issue letters to inform local healthcare professionals on the risk of DKA with SGLT2 inhibitors including Forxiga. So far, DH has received one adverse drug reaction case of ketoacidosis after taking Forxiga. As previously reported, the above health authorities are continuing to review the safety of Forxiga to determine whether changes to the prescribing information are needed. DH will remain vigilant on future announcements by overseas health authorities related to Forxiga for consideration of any actions deemed necessary.
Ends/ Wednesday, July 22, 2015
Issued at HKT 13:00
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