June 16th, 2014

European Regulators Investigate Cardiovascular Safety of Ibuprofen

The European Medicines Agency announced on Friday that it had initiated a review of the cardiovascular safety of ibuprofen when taken in high doses over an extended period of time. The review will be performed by the Pharmacovigilance Risk Assessment Committee (PRAC).

The EMA said that people taking ibuprofen should continue to take it as long as they follow the package label or the instructions of their physician or pharmacist.

The cardiovascular risk of all non-steroidal anti-inflammatory drugs (NSAIDs) has been under close scrutiny for a number of years. The increased risk associated with one group of NSAIDs, the COX-2 inhibitors, has been known for more than a decade. Researchers have also found evidence for cardiovascular problems with the NSAID diclofenac.

The EMA said it had found no evidence for a problem in people taking doses less than 2400 mg/day or for short periods of time. “Ibuprofen is one of the most widely used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses,” the agency said.


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