ADR that result in revision of patient information
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| Canada: Summary Safety Review: Colistin (colistimethate sodium): Assessing the potential risk of pseudo-Bartter syndrome |
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Health Canada announces that it reviewed the potential risk of pseudo-Bartter syndrome with the use of colistin (colistimethate sodium). The safety review was triggered by published cases of pseudo-Bartter syndrome with the use of colistin (colistimethate sodium) in the scientific literature.
Pseudo-Bartter syndrome is an acquired condition (not passed on from a parent) primarily presenting as metabolic alkalosis (an acid-base disorder), hypokalemia (low blood potassium) and other electrolyte abnormalities. Colistin (colistimethate sodium) is a prescription antibiotic drug authorized for sale in Canada to treat acute or chronic infections.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, and scientific literature. At the time of the review, Health Canada had not received any Canadian reports of pseudo-Bartter syndrome related to the use of colistin (colistimethate sodium). Health Canada reviewed 7 international cases of pseudo-Bartter syndrome in patients who were administered colistin (colistimethate sodium). All 7 cases were identified in the published literature. Of the 7 cases reviewed, 6 were found to be probably linked to the use of colistin (colistimethate sodium), and 1 was found to be possibly linked. In all 7 cases, hypokalemia, metabolic alkalosis, and loss of potassium in the urine were reported. Some cases also involved hypomagnesemia (low blood magnesium) and hypocalcemia (low blood calcium). In all 7 cases, electrolyte abnormalities resolved or significantly improved following the discontinuation of colistin (colistimethate sodium).
Health Canada’s review of the available information found a link between the use of colistin (colistimethate sodium) and the risk of pseudo-Bartter syndrome. Health Canada is working with the manufacturers to update the Canadian product monograph for colistin (colistimethate sodium)-containing products with a warning about reported cases of pseudo-Bartter syndrome.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1705515920269
In Hong Kong, there are 3 registered pharmaceutical products containing colistin (colistimethate sodium) for human use. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to colistin (colistimethate sodium). In light of the above Health Canada’s announcement, letters 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/Friday, Mar 1, 2024
Issued at HKT 15:30
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