GPs are being warned to check patients’ risk for cardiovascular disease carefully before initiating long-term ibuprofen, particularly at high doses, following a review by the European drugs regulator.
European Medicines Agency (EMA) advisors have recommended that the product information for ibuprofen should be updated to warn about a ‘small’ increase in risk of heart attacks and strokes when the drug is taken at high doses, after their review showed the risks with high-dose ibuprofen – 2,400 mg or more per day – were similar to those seen with certain other NSAIDs, including COX-2 inhibitors and diclofenac.
The recommendations for ibuprofen also apply to the similar drug dexibuprofen, for which a high dose is 1,200 mg per day or higher.
The Committee did not recommend any change in advice on use of ibuprofen at lower doses up 1,200 mg per day – the highest dose generally used for over-the-counter ibuprofen tablets.
The EMA’s Pharmacovigilance Risk Assessment Committee was tasked with reviewing the evidence on ibuprofen last June.
It has now concluded that while the benefits of ibuprofen outweigh the risks overall, the product information should be updated to highlight that ‘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 Committee added that ‘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’, and that ‘risk factors for these conditions include smoking, high blood pressure, diabetes and high blood cholesterol’.
The experts also ruled that information about a potential interaction between ibuprofen and low-dose aspirin should be added to the product information. However they added that there is still uncertainty about the effect, and that occasional use of ibuprofen should not affect the benefits of low-dose aspirin for heart disease prevention.