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PRAC Review of Ibuprofen

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as taken orally and not topical like gels and creams).

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. 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 wether current advice to Healthcare profesionals is sufficient.

The EMA stated that, 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.

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