ADR that result in revision of patient information
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| Australia: Product deregistration: Oral ketoconazole (Nizoral) 200 mg tablets |
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Consumers and health professionals are advised that Janssen-Cilag (Australia), in consultation with the Therapeutic Goods Administration (TGA), is deregistering and discontinuing supply of oral ketoconazole (Nizoral) 200 mg tablets in Australia, commencing 1 December 2013.
Oral ketoconazole is an antifungal medicine that kills or stops the growth of certain types of fungi or yeasts, which cause infection. Liver injury is a known risk associated with oral ketoconazole treatment and, for this reason, a number of risk minimisation measures have been in place for a number of years.
Topical ketoconazole (Nizoral cream and shampoo) is not affected by this and will continue to be available.
TGA advised health professionals that commencing treatment with oral ketoconazole for new patients is not recommended. If a patient is already being treated with oral ketoconazole, consider switching them to an alternative antifungal therapy. If a patient continues taking oral ketoconazole, treatment duration should be restricted to a maximum of four weeks, with a maximum daily dose of less than or equal to 400 mg. Monitoring of liver function is also strongly advised. If these tests indicate liver injury, health professionals should stop treatment immediately. Health professionals are advised to instruct patients being treated with oral ketoconazole to promptly seek medical attention if they experience signs of liver injury, such as anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-oral-ketoconazole-131010.htm
In Hong Kong, there are 24 oral ketoconazole-containing registered pharmaceutical products. All of them are prescription-only medicines. Related news had been released by CFDA, Health Canada, EMA, MHRA and FDA, and was posted on the Drug Office website on 1 September 2011, 20 June 2013 and 27 July 2013. Letters to inform healthcare professionals to draw their attention on the issue and urge them to report adverse drug reactions related to oral ketoconazole were issued on 1 September 2011 and 29 July 2013. The matter was discussed by the Registration Committee (the Committee) of the Pharmacy and Poisons Board in February 2012 and September 2013, and the Committee decided that more information should be necessary for re-consideration. The Department of Health will keep vigilant on any safety updates of the drug.
Ends/ Thursday, October 10, 2013
Issued at HKT 14:00 |
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