ADR that result in revision of patient information
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| Taiwan: Risk communication on drug safety information for Non-steroidal Anti-inflammatory Drugs (NSAIDs) |
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In Hong Kong, NSAID-containing products are registered pharmaceutical products with ingredients such as aspirin, diclofenac, ibuprofen, naproxen, indomethacin, mefenamic acid and piroxicam. Except ibuprofen which is a pharmacy-only medicine and aspirin which is an over-the-counter medicine, products containing other ingredients are prescription-only medicines.
Safety warning regarding the cardiovascular risks associated with NSAIDs has been released by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2011. On 30 September 2011 and 7 October 2014, letters to healthcare professionals were issued to draw their attention to the warning. The last update on the associated risk was posted on the Drug Office website on 10 July 2015, and it was about the strengthening of warning on increased chance of heart attack or stroke for this class of drugs by the US FDA.
The matter related to cardiovascular risk of NSAIDs was discussed in the meeting of the Registration Committee of the Pharmacy Poisons Board (the Committee) in February 2013. The Committee concluded that NSAID-containing products, other than external preparations and aspirin, should include new safety warnings regarding the cardiovascular risk. So far, the DH has received 13 cases of adverse drug reaction on NSAIDs, and none of them were related to cardiovascular event. As previously reported, in view of the latest news of the US FDA, the matter will be further discussed in the meeting of the Committee.
Please refer to the following Chinese website for details:
http://www.drugoffice.gov.hk/eps/news/../25030.html
Ends/ Thursday, August 13, 2015
Issued at HKT 15:00
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