ADR that result in revision of patient information
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| Canada: Summary Safety Review - Sodium/glucose cotransporter 2 (SGLT2) inhibitors - Assessing the potential risk of inflammation of the pancreas (acute and chronic pancreatitis) |
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Health Canada announces that it reviewed the potential risk of pancreatitis with the use of sodium/glucose cotransporter 2 (SGLT2) inhibitors (dapagliflozin, canagliflozin and empagliflozin) because of Canadian reports and case reports published in the scientific literature that indicated a possible link.
At the time of the review, Health Canada had received 20 Canadian reports of acute pancreatitis related to the use of SGLT2 inhibitors and no reports of chronic pancreatitis. Of these reports, 1 was further assessed as it met the criteria defined for this review. This Canadian report showed a possible link between acute pancreatitis and the use of an SGLT2 inhibitor. The review also looked at 476 international reports and 6 published cases of pancreatitis related to the use of SGLT2 inhibitors. Of these reports, 28 cases of acute pancreatitis, but no cases of chronic pancreatitis, were further assessed as they met the criteria defined for this review. Of the 28 reports, 18 showed a possible link between acute pancreatitis and the use of a SGLT2 inhibitor. In most of the remaining reports, other medical conditions and medications could have caused the pancreatitis. A review of the scientific literature did not find any published studies that showed an increased risk of pancreatitis in patients treated with SGLT2 inhibitors.
Health Canada's review of the available information concluded that there may be a link between the use of SGLT2 inhibitors and the risk of acute pancreatitis. However, there was limited evidence to suggest a link with chronic pancreatitis. Health Canada is working with the manufacturers to update the product safety information for SGLT2 inhibitors to inform healthcare professionals and patients about this risk.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00204
In Hong Kong, there are 17 registered pharmaceutical products containing SGLT2 inhibitors, including dapagliflozin (5 products), canagliflozin (2 products) and empagliflozin (10 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to dapagliflozin, 2 cases related to canagliflozin and 1 case related to empagliflozin, but these cases are not related to pancreatitis. In light of the above Health Canada’s announcement, letter to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Jul 24, 2018
Issued at HKT 16:00
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