ADR that result in revision of patient information
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| Canada: KETOCONAZOLE - Risk of potentially fatal liver toxicity |
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The manufacturers of oral KETOCONAZOLE, in collaboration with Health Canada, informed the healthcare professionals and the public about the revisions to the Product Monograph for KETOCONAZOLE regarding the risk of potentially fatal liver toxicity. KETOCONAZOLE has been associated with rare cases of serious hepatotoxicity including liver failure and death. This risk was also observed in patients with no pre-existing liver disease and no serious underlying medical conditions. Hepatotoxicity and death have been reported to occur at recommended doses and with treatment courses longer than 10 days. The Warnings' sections of the Product Monographs have been updated to include the following additional instructions:
- KETOCONAZOLE tablets are indicated for the treatment of serious or life threatening systemic fungal infections and should not be considered for mild to moderate infections.
- Oral KETOCONAZOLE has been associated with hepatic toxicity, including cases with fatal outcomes.
- Liver function tests should be performed in all patients before starting treatment, at week 2 and 4, and monthly thereafter.
- Treatment should be stopped if liver parameters are elevated (> 3 times the normal limit) or if patients develop clinical signs or symptoms consistent with liver disease such as anorexia, nausea, vomiting, jaundice, fatigue, abdominal pain, dark urine, or pale stools.
Healthcare practitioners should consider the risk of fatal liver toxicity with KETOCONAZOLE when prescribing antifungal treatment for patients who are already at risk for liver toxicity. Patients using KETOCONAZOLE concurrently with potentially hepatotoxic drugs should be carefully monitored, especially in those expected to be on prolonged therapy or at risk for hepatotoxicity.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../34173a-eng.php
In Hong Kong, there are 24 oral ketoconazole-containing pharmaceutical products registered and all are prescription-only medicines. Related news has been released by China Food and Drug Administration and was posted on the Drug Office website on 1 September 2011. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to oral ketoconazole was issued on the same day. The matter was discussed by the Registration Committee of the Pharmacy Poisons Board in the meeting in February 2012 and the Committee decided that the Drug Office should keep vigilant about this safety issue. In view of Health Canada's recommendations, the matter will be further discussed in the Registration Committee.
Ends/ Thursday, June 20, 2013
Issued at HKT 12:30
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