European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the 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 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).
The PRAC concluded that the benefits of ibuprofen outweigh the risks but recommended updating advice on the use of high-dose ibuprofen 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.
In addition, doctors should carefully assess a patient’s risk factors for heart or circulatory conditions, before initiating long-term treatment with ibuprofen, particularly if high doses are required. Risk factors for these conditions include smoking, high blood pressure, diabetes and high blood cholesterol.
The PRAC also reviewed data on the interaction between ibuprofen and low-dose aspirin when the latter is taken to reduce the risk of heart attacks and strokes. The PRAC noted that ibuprofen has been shown in laboratory studies to reduce the anti-clotting 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 PRAC recommended that updated advice on the cardiovascular risk of high-dose ibuprofen be included in the product information of ibuprofen medicines, along with information on the available evidence on the interaction between ibuprofen and aspirin. The recommendations for ibuprofen also apply to dexibuprofen, a medicine similar to ibuprofen. A high dose of dexibuprofen is a dose at or above 1,200 mg per day. The PRAC recommendations for ibuprofen and dexibuprofen will now be sent the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position.
A class warning of this risk is already in place and the product information for all NSAIDs, including ibuprofen, recommends that these medicines be used at the lowest effective dose and for the shortest period of time necessary to control symptoms. This current review considered accumulated evidence which clarifies the cardiovascular risk related to ibuprofen taken at high doses and the interaction between ibuprofen at any dose and aspirin.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002306.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 84 registered pharmaceutical products (excluding external preparations) containing ibuprofen, and are pharmacy-only medicines. There are no registered pharmaceutical products containing dexibuprofen. Safety alerts regarding the cardiovascular risks associated with NSAIDs has been released by various overseas health authorities, and was posted on the Drug Office website since 2011. Letter to healthcare professionals to draw their attention to the issue 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. So far, the Department of Health has not received any adverse drug reaction reports on ibuprofen. In view of the latest EMA's announcement which clarifies the cardiovascular risk related to ibuprofen taken at high doses and the interaction between ibuprofen at any dose and aspirin, the matter will be further discussed in the meeting of the Committee.
Ends/ Tuesday, April 14, 2015
Issued at HKT 14:00
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