Drug treatments for acid reflux are facing new FDA scrutiny

The agency is investigating if PPIs negatively affect the heart, although early analysis suggests not. Also, a recent study associates H2 blockers with cognitive decline.

By Victoria Stagg Elliott, AMNews staff. Sept. 17, 2007.

The effects of Food and Drug Administration action and a study published last month have combined to bring attention to possible adverse effects of proton pump inhibitors, the drugs commonly used to treat acid reflux.

On the regulatory side, the FDA announced Aug. 9 that a safety review had been initiated of Prilosec (omeprazole) and Nexium (esomeprazole). The agency took this step in response to data from two small, long-term studies that compared results from the use of these medications to surgery in patients with severe gastroesophageal reflux disease.

Initially, the study findings seemed to imply that chronic use of these drugs was associated with an increased risk of heart attack. A preliminary analysis, however, suggested that this outcome is not a true effect but a bias caused by the study design.

A final conclusion is expected within three months.

"The studies that suggested the signal were small and not designed to look at this endpoint. It was readily apparent, when using the standard rules of evidence, that it was easy to ascertain a number of study biases," said David A. Johnson, MD, president of the American College of Gastroenterology.

The FDA is not calling for any changes in how these drugs are used, and AstraZeneca Pharmaceuticals LP, the manufacturer of both drugs, issued a statement underscoring this agency position. Many physicians also agreed with this position.

"It would be premature to do anything clinically with respect to these data," said Nicholas J. Shaheen, MD, MPH, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine in Chapel Hill.