Other safety alerts
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| Canada: Ursodiol (ursodeoxycholic acid, UDCA) - association of high-dose with serious liver side effects |
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The manufacturers of ursodiol (Aptalis Pharma Canada Inc., Dominion Pharmacal, Pharmascience Inc., Pharmel Inc., Teva Canada Ltd.), in consultation with Health Canada, would like to inform healthcare professionals the important new information regarding ursodiol (ursodeoxycholic acid, UDCA). In a 5-year randomized, double-blind, clinical trial, 150 primary sclerosing cholangitis (PSC) patients were treated with placebo or twice the recommended dose of ursodiol. Serum AST and ALP concentrations decreased more in the ursodiol than the placebo treated group (p<0.01), but improvements in liver function tests were not associated with decreased endpoints. The risk was 2.1-fold greater for death, liver transplantation or minimal listing criteria in the high-dose ursodiol group (p<0.05). Serious adverse events (including varices, cirrhosis, and cholangiocarcinoma) were more common in the ursodiol than the placebo group (63% versus 37%; p < 0.01). The Product Monographs for ursodiol have been revised to describe the clinical trial, and advise that improved serum liver tests (e.g. AST, ALP) do not always correlate with an improved liver disease status. The PMs continue to recommend monitoring of GGT, alkaline phosphatase, AST, ALT and bilirubin every month for three months after start of therapy, and every six months thereafter. Treatment should be discontinued if the levels of these parameters increase.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/ursodiol_hpc-cps-eng.php
In Hong Kong, there are 10 registered pharmaceutical products containing ursodeoxycholic acid and 8 of them contain ursodeoxycholic acid as single ingredient products. Department of Health has contacted the Health Canada for the details of the clinical trials concerned. Any further updates made by Health Canada and other regulatory authorities will be kept in view. In view of Health Canada's recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board. Press release will also be issued today.
Ends/ Tuesday, December 6, 2011
Issued at HKT 17:30
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