EMA Wants Updated Advice on CV Risk of High-Dose Ibuprofen

A drug safety committee in the EU wants manufacturers of ibuprofen to warn patients of a slightly increased risk of cardiovascular death when the painkiller is taken in high doses.

A review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee confirmed a link between use of the nonsteroidal anti-inflammatory in doses at or above 2,400 mg per day and events such as heart attack and stroke.

While the benefits of ibuprofen outweigh these risks, advice on use of ibuprofen should be updated, including in the product’s labeling information, PRAC says.

The recommendations also apply to dexibuprofen, a similar NSAID, when taken in doses at or above 1,200 mg per day.

The committee’s conclusions are consistent with previous findings related to cardiovascular risks associated with NSAIDs, including COX-2 inhibitors and diclofenac. In August 2013, The Lancet reported on a large international study that showed extended high-dose use of painkillers such as ibuprofen or diclofenac carried the same risk of heart attack as Vioxx (rofecoxib), which was withdrawn by Merck due to safety concerns.

According to the researchers, high doses of NSAIDs could increase a patient’s risk of heart attack, stroke or death by about a third.

The EMA is not the first regulatory authority to recommend warning statements for NSAIDs. Earlier this year, Australia’s Therapeutic Goods Administration proposed distributing warning labels about cardiovascular safety concerns associated with excessive or prolonged NSAID use.

PRAC will now send its recommendations for ibuprofen and dexibuprofen, another NSAID, to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, a body representing the EU, Iceland, Norway and Liechtenstein, for a final position. — Jessica Grinspan