EMA Committee Warns of Small Cardiovascular Risk With High-Dose Ibuprofen


April 13, 2015

LONDON, UK — The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is warning of an increased risk of cardiovascular events in patients who take high doses of the anti-inflammatory ibuprofen[1].

The committee, which began its review in 2014, states there is a small increase in the risk of MI and stroke with ibuprofen when taken at doses of 2400 mg/day or higher. The risk, according to the committee, is similar to the risk observed with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as COX-2 inhibitors and diclofenac.

In 2013, as reported by heartwire , researchers published data showing diclofenac, a drug used for pain and inflammation, increased the risk of cardiovascular events between 38% and 63% in different studies. The EMA reached similar conclusions in 2012, concluding there was a consistent but small increase in the risk of cardiovascular side effects with diclofenac compared with other NSAIDs.

The committee is recommending physicians assess patients' risk factors for cardiovascular conditions before starting them on long-term high-dose ibuprofen. Overall, PRAC says the benefits of high-dose ibuprofen outweigh the small increased risk of cardiovascular events, but physicians should use caution when prescribing and avoid high-dose ibuprofen in select patients.

"High doses of ibuprofen (2400 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," according to PRAC.

With 1200 mg of ibuprofen, the most commonly used over-the-counter dose of ibuprofen in the European Union, there is no signal of harm, according to PRAC. The recommendations of the committee also extend to dexibuprofen, which is similar to ibuprofen. A high-dose of dexibuprofen is 1200 mg/day or more.

The recommendations of PRAC will now be sent to the Coordination Group for Mutual Recognition for Decentralized Procedures—Human (CMDh). The CMDh reviews the recommendations of PRAC and will adopt a final position.


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