ADR that result in revision of patient information
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| European Union: Updated advice on use of high-dose ibuprofen - Review confirms small cardiovascular risk with daily doses at or above 2,400 mg |
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The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by consensus updated advice on the use of high-dose ibuprofen. This follows a review carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a small increased risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.
No increase in cardiovascular risk is seen with ibuprofen at doses of up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).
To minimise the cardiovascular risk, high doses of ibuprofen (2,400 mg per day or higher) should be avoided in patients with serious underlying heart or circulatory conditions, such as heart failure, heart disease and circulatory problems or in those who have previously had a heart attack or stroke.
The review also looked at data on the interaction between ibuprofen and low-dose aspirin when the latter is taken to reduce the risk of heart attacks and strokes. Laboratory studies have shown that ibuprofen reduces the blood-thinning effects of aspirin. However, it remains uncertain whether long-term use of ibuprofen in clinical practice reduces the benefits of low-dose aspirin in preventing heart attacks and strokes. Occasional use of ibuprofen should not affect the benefits of low-dose aspirin.
The updated advice on the cardiovascular risk of high-dose ibuprofen will be included in the product information of ibuprofen medicines, along with information on the interaction between ibuprofen and aspirin.
Please refer to the following website in EMA for details:http://www.ema.europa.eu/../news_detail_002337.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 87 registered pharmaceutical products (excluding external preparations) containing ibuprofen, and are pharmacy-only medicines. Safety alerts regarding the cardiovascular risks associated with NSAIDs has been released by various overseas regulatory authorities, and was posted on the Drug Office website since 2011. Letter to healthcare professionals to draw their attention to the alerts was issued on 30 September 2011. The matter related to cardiovascular risk of NSAID was discussed in the meeting of the Registration Committee of the Pharmacy Poisons Board (the Committee) in February 2013. The Committee concluded that NSAIDs-containing products, other than external preparations and aspirin, should include new safety warnings regarding the cardiovascular risk. Latest news specifically on cardiovascular risk related to high dose ibuprofen has been released by the EMA and the Health Canada, and was posted on the Drug Office website on 14 April 2015 and 24 April 2015 respectively. As previously reported, the matter will be further discussed in the Committee's meeting. In view of the latest EMA's announcement, the information will also be forwarded to the Committee for consideration. The DH will remain vigilant on any safety updates of the drug by other overseas regulatory authorities.
Ends/Saturday, May 23, 2015
Issued at HKT 12:00
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