No Increased Heart-Attack Risk

The Food and Drug Administration said Monday a review of clinical studies involving AstraZeneca PLC's reflux drugs Nexium and Prilosec don't show an increase in heart attacks and sudden death.

The agency has been conducting a safety review of the drugs, which are approved to treat gastroesophageal reflux disease, since May, when AstraZeneca submitted the results of two small, long-term studies that suggested the drug could increase the risk of heart problems and sudden death. Prilosec is also approved in an over-the-counter version and is marketed by Procter & Gamble Co. to treat frequent heartburn.

The studies were designed to assess the effectiveness of treatment with Prilosec, or Nexium, or surgery for severe GERD. The FDA said cardiovascular events seen in the small studies raised a question about whether long-term use of the drugs increases the risk of heart attacks, heart failure and heart-related sudden death in patients taking either one of the prescribed drugs compared with patients who received surgical treatment.

The FDA said it then asked AstraZeneca to submit additional information about the drugs for FDA to review.

The agency said its review of the two long-term studies submitted in May along with 14 additional studies show the products are "not likely to be associated with an increased risk of heart problems."

The agency said the increase in heart-related problems seen in the two small, long-term studies "does not indicate the presence of a true effect."

The agency said it recommends "that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs."

Prilosec and Nexium are members of a class of drugs known as proton pump inhibitors, or PPIs. They work to decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis. They are also indicated for use with an antibiotic to treat gastric ulcers, the FDA said.