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| European Union: European Medicines Agency starts review of ibuprofen medicines (English Only) |
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The European Medicines Agency's Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels).
The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken at lower doses and for short periods of time.
There is therefore no suggestion of a similar cardiovascular risk with ibuprofen as used by the overwhelming majority of patients. Ibuprofen is one of the most widely used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses.
Ibuprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The safety of these medicines including their cardiovascular risks has been under close review by the European Medicines Agency (EMA) and national regulatory authorities for many years. Data, in particular the results of a published analysis of clinical trial data, have suggested that the cardiovascular risk with diclofenac and high-dose ibuprofen (2,400 mg) may be similar to the known risk with COX-2 inhibitors (also of the NSAID class). In 2013, the PRAC considered the available data relating to diclofenac and issued recommendations to minimise their risks. The PRAC is now considering the available data relating to high-dose ibuprofen.
The PRAC will also evaluate evidence on the interaction of ibuprofen with low-dose aspirin (taken to reduce the risk of heart attacks and strokes) to decide whether current advice to healthcare professionals is sufficient.
While the review is ongoing, patients should continue to use their medicines as per the instructions in the package leaflets or as directed by their doctor or pharmacist.
As ibuprofen-containing medicines are all authorised nationally, the PRAC recommendation will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures –Human (CMDh), which will adopt a final position.
Please refer to the following website of EMA for details:
http://www.ema.europa.eu/../news_detail_002125.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 76 registered pharmaceutical products (excluding external preparations) containing ibuprofen and are pharmacy-only medicines. Safety alerts regarding NSAIDs associated with cardiovascular risks had been released by MHRA, EMA and HSA, and was posted on the Drug Office website on 30 September 2011, 22 October 2011, 20 October 2012, 31 May 2013, 15 June 2013, 29 June 2013, 1 March 2014 and 26 April 2014. Letter to inform healthcare professionals to draw their attention on the issue regarding NSAIDs and risk of heart problems and urge them to report any adverse drug reaction related to NSAIDs was issued on 30 September 2011. The matter was discussed by the Registration Committee of the Pharmacy Poisons Board (the Registration Committee) in the meeting in February 2013 and the Registration Committee concluded that NSAIDs-containing products other than external preparations should include new safety warnings regarding the cardiovascular risk. Drug Office will remain vigilant on any new safety update on ibuprofen and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, June 14, 2014
Issued at HKT 12:45
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