Report contradicts FDA warning against use of anti-clotting drug with proton-pump inhibitors

Mark Hlatky

It’s appropriate for heart patients who need to take the anti-clotting drug clopidogrel and who also have a high risk of gastrointestinal bleeding to receive a prescription for acid-reducing medications called proton-pump inhibitors such as pantoprazole, according to a new consensus document issued Nov. 8 by three medical groups.

The benefits outweigh the potential risks, according to the document, which contradicts last year’s warning to patients by the U.S. Food and Drug Administration that the two therapies should not be combined because the proton-pump inhibitors could reduce the efficacy of clopidogrel by 50 percent.

Clopidogrel is marketed as Plavix; pantoprazole, which is sold under the brand name Protonix, is one of a half dozen or so proton-pump inhibitors.

“In patients at high risk of GI bleeding who require antiplatelet therapy for heart disease, the balance of risk and benefit favor use of proton-pump inhibitors,” said Mark Hlatky, MD, professor of cardiovascular medicine and vice chair of the writing committee that produced the document on the combined therapy. “In patients at low risk of GI bleeding, however, the balance of risk and benefit tips away from using proton-pump inhibitors together with antiplatelet drugs.”

Clopidogrel is widely used to prevent blood clotting in patients who have undergone bypass surgery, angioplasty, stenting and other procedures. Because it can increase susceptibility to bleeding, physicians often prescribe acid-reducing drugs to lower this risk. The FDA recommended replacement of proton-pump inhibitors by another class of drugs that is not as effective.

The three medical groups involved were the American College of Cardiology Foundation, the American College of Gastroenterology and the American Heart Association. The committee’s work was funded by the American College of Cardiology Foundation with no contributions from industry.