其 他 安 全 警 示
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| Canada: Summary Safety Review - Systemic and Inhaled Fluoroquinolone Antibiotics - Assessing the Potential Risk of Heart Valve Regurgitation (English only) |
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Health Canada announces that it has reviewed the potential risk of heart valve regurgitation in patients treated with systemic or inhaled fluoroquinolones following information received from the European Medicines Agency (EMA) related to this risk. Health Canada’s review did not include fluoroquinolone products for use in the eyes (ophthalmic) or ears (otic), since this risk has not been reported with these formulations.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, and published literature. At the time of the review, Health Canada had not received any Canadian reports of heart valve regurgitation related to fluoroquinolone use.
Health Canada reviewed 5 international case reports of heart valve regurgitation in patients receiving a fluoroquinolone that were retrieved from the Canada Vigilance database. Of the 5 case reports, 2 cases were found to be possibly linked with the use of a fluoroquinolone, 2 cases were unlikely to be linked, and one case did not have enough information to be assessed further. Health Canada’s review of 2 articles in the scientific literature did not support a link between heart valve regurgitation and the use of fluoroquinolones. The first study reported an increased risk of heart valve regurgitation with fluoroquinolone use; however, limitations in the study design make the findings difficult to interpret. The second study did not have enough information to be assessed further.
Health Canada’s review of the available information did not establish a link between the use of systemic or inhaled fluoroquinolones and the risk of heart valve regurgitation. Health Canada will continue to monitor safety information involving fluoroquinolones to identify and assess potential harms and will take appropriate and timely action should new health risks be identified.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00272
In Hong Kong, there are registered pharmaceutical products containing systemic fluoroquinolones for use in human, including ciprofloxacin (67 products), levofloxacin (50 products), moxifloxacin (7 products), norfloxacin (3 products), ofloxacin (20 products) and prulifloxacin (1 product). All products are prescription-only medicines. So far, the Department of Health (DH) has received 9 cases of adverse drug reaction related to levofloxacin and 1 case related to moxifloxacin, but these cases are not related to heart valve regurgitation.
Related news was previously issued by the Taiwan Food and Drug Administration (TFDA), United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and Singapore Health Sciences Authority and was posted on the Drug Office website on 4 Dec 2020, 18 Dec 2020 and 13 May 2021 respectively. Letters to inform local healthcare professionals were issued by the DH on 4 Dec 2020. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, Aug 28, 2021
Issued at HKT 12:00
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