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EMA investigates CV safety of ibuprofen

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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has initiated a review to assess the CV risks posed by oral systemic ibuprofen medicines, the agency announced in a press release.

The investigation pertains to high doses of ibuprofen (2,400 mg per day) taken consistently over long time periods, which is not the way the drug is usually taken by the majority of consumers. The usual dose of ibuprofen for adults and children aged over 12 years is 200 mg to 400 mg, three or four times daily as needed.

“There is, therefore, no suggestion of a similar CV risk with ibuprofen as used by the overwhelming majority of patients,” the European Medicines Agency (EMA) said in the release. “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 EMA and national regulatory authorities have been monitoring the safety of non-steroidal anti-inflammatory drugs (NSAIDs) for several years. According to one published analysis of clinical trial data, high-dose ibuprofen and diclofenac may pose CV risks similar to those associated with COX-2 inhibitors. Based on this and other available data relating to diclofenac, the Pharmacovigilance Risk Assessment Committee (PRAC) issued recommendations for minimizing these risks. The PRAC is now similarly evaluating accessible data on high-dose ibuprofen, according to the release.

Additionally, the PRAC will assess data regarding the combined use of ibuprofen and low-dose aspirin, and investigate whether the current guidance for this combination is adequate.

The EMA added that while the review is underway, patients should continue the use of any medicines they are currently taking according to the package leaflets or as instructed by their health care provider.

The PRAC’s recommendation will be forwarded to the Coordination Group for Mutual Recognition and Decentralized Procedures - Human, which in turn will determine a final position, the EMA stated in the release.