ADR that result in revision of patient information
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| China：CFDA warns against proton pump inhibitors – risk of fractures and hypomagnesaemia as well as drug interactions with clopidogrel |
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In Hong Kong, there are 157 registered pharmaceutical products belonging to the class of proton pump inhibitors, which include the ingredients esomeprazole, lansoprazole, dexlansoprazole, omeprazole, pantoprazole and rabeprazole. All these products are prescription-only medicines except the products containing omeprazole which are pharmacy only medicines. Related news regarding the potential risk of fractures and hypomagnesaemia associated with proton pump inhibitors as well as the drug interactions with clopidogrel had been released by the Department of Health and various overseas regulatory authorities, and were posted on the Drug Office website. Letters to inform healthcare professionals to draw their attention on the issues and urge them to report any adverse drug reaction related to the drugs were issued on 26 May 2010 and 3 March 2011. The issues were discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee) in June 2010, May 2011, April and August 2012. The Committee decided that the sales pack labels and/or package inserts of pharmaceutical products containing proton pump inhibitors should include the safety information on the potential risk of hypomagnesaemia and drug interactions with clopidogrel. As reported on 20 October 2012, the matter related to the risk of fractures will be further discussed in the meeting of the Committee. Department of Health will keep vigilance on any updated safety news of the drugs.
Please refer the following Chinese website for details:
http://www.drugoffice.gov.hk/eps/news/../19683.html
Ends/ Monday, June 03, 2013
Issued at HKT 12:00
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