Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2014

News 13/06/2014

Review of ibuprofen medicines started

At its June 2014 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) 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).

Ibuprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The review, which follows the PRAC's work in examining the risks of other medicines of this class, concerns the cardiovascular risks of 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.

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.

For an overview of all information available following the meeting of the PRAC, see the table below.


PDF icon Agenda - PRAC draft agenda of meeting 10-13 June 2014

Start of referral procedure

Ibuprofen- and dexibuprofen-containing medicines

Article-31 referral: Ibuprofen- and dexibuprofen-containing medicines

PDF icon Review started
PDF icon Referral notification
PDF icon PRAC list of questions
PDF icon Timetable for the procedure

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