Other safety alerts
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| Canada: Summary Safety Review - Systemic fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin and norfloxacin) |
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Health Canada announces that it has carried out a safety review of the potential risk of aortic aneurysm and aortic dissection with the use of fluoroquinolones. The safety review was triggered by published studies, including one study conducted in Canada.
An aortic dissection is a tear of the inside lining of the aorta, the major blood vessel that carries blood from the heart to the rest of the body. An aortic aneurysm is a balloon-like bulge in the wall of the aorta. A rupture of the aneurysm can cause bleeding and, in the most serious cases, may lead to death. Patients with an aortic aneurysm frequently do not show any symptoms and the aneurysm may not be diagnosed until it ruptures. Both aortic dissection and ruptured aneurysm can cause severe pain and death. While a tear and bulge can occur in any artery, they are most common in the aorta. High blood pressure (hypertension) and the build-up of plaques inside arteries (atherosclerosis) are major risk factors for aortic dissections and/or aneurysms
At the time of the review, Health Canada received 28 international published reports, and 4 Canadian reports of aortic aneurysms and dissections with the use of fluoroquinolones. Of the Canadian reports, 3 were further assessed as they met the criteria defined for the review. One report showed a possible link between aortic aneurysm and the use of levofloxacin. The other 2 cases could not be assessed due to insufficient information.
Health Canada also looked at the scientific literature and focused on 4 published studies. Although there were limitations to these studies, they showed an approximately two-fold increased risk of aortic aneurysm and dissection in patients treated with fluoroquinolones, including one Canadian study.
The review has concluded that there may be a link between the use of systemic fluoroquinolones (given by mouth, by injection, or by inhalation) and aortic aneurysm and dissection. Given the frequent use of fluoroquinolones in Canada and the information reviewed, these side effects are considered rare.
Health Canada recommended that the product safety information for all systemic fluoroquinolone products be updated to include information about this rare but serious adverse effect. In addition, it will inform Canadians and healthcare professionals of this new safety information; and is working with the manufacturers to update the product safety information of all systemic fluoroquinolone products marketed in Canada.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00226
In Hong Kong, there are 181 registered pharmaceutical products containing fluoroquinolones which are oral preparations or injectables for use in human, including ciprofloxacin (79 products), levofloxacin (60 products), moxifloxacin (6 products), norfloxacin (6 products), ofloxacin (29 products) and prulifloxacin (1 product). All products are prescription-only medicines. So far, the Department of Health (DH) has received 6 cases of adverse drug reaction related to levofloxacin and 1 case related to moxifloxacin, but these cases are not related to aortic aneurysm and dissection.
Related news was previously issued by Medicines and Healthcare products Regulatory Agency (MHRA), US FDA, Singapore Health Sciences Authority, and Therapeutic Goods Administration; and was posted on the Drug Office website on 15 Nov 2018, 21 Dec 2018, 9 Mar 2019 and 13 April 2019 respectively. Letters to inform local healthcare professionals were issued by the DH on 15 Nov 2018. In June 2019, the Registration Committee of the Pharmacy and Poisons Board decided that the sales pack labels and/or package inserts of registered pharmaceutical products containing fluoroquinolones for systemic use should be updated and include the warnings for the risk of aortic aneurysm and dissection. The DH will keep vigilant on other safety updates from other overseas drug regulatory authorities.
Ends/ Friday, June 28, 2019
Issued at HKT 17:00
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