On August 9, 2007, the U.S. Food and Drug Administration (FDA) said it found no firm evidence linking AstraZeneca’s heartburn drugs to an increased risk of heart problems, despite some evidence that suggested otherwise.

AstraZeneca presented data from two small, long-term studies to health authorities in May 2007. The study compared heartburn patients who took Nexium and Prilosec or had gastroesophageal reflux disease (GERD) surgery. Initially, the FDA said the new data raised concerns about long-term use of the drugs potentially increasing the risk of heart attacks, heart failure and heart-related sudden cardiac death when compared with surgery.

Notwithstanding those concerns, the agency said it has reached the preliminary conclusion that the data does not suggest an increase in heart risks.

“FDA does not believe that health-care providers or patients should change either their prescribing practices or their use of these products at this time,” read the FDA website.

Some of the new data presented was from a 14-year study and suggested patients on Prilosec had more heart problems than patients who underwent GERD surgery.

The FDA said the resulting problems may not lie with the drugs, but instead with inconsistencies in the study. Many of the study’s patients assigned to undergo surgery withdrew before the procedure, and those who did undergo surgery were younger and less likely to have a past history of heart problems.

The data presented to the FDA was clinical-trial data for more than 50,000 patients. The agency expects to complete its continuing review within three months.

Prilosec and Nexium are in a class of drugs called protein pump inhibitors (PPIs) and treat GERD by reducing the amount of acid produced by the stomach. Prilosec is also sold over-the-counter for frequent heartburn.

Sources: “Early communication about an ongoing safety review,” US Food and Drug Administration Press Release, August 9, 2007; Peter Loftus, “FDA to review heartburn drugs,” Wall Street Journal, August 9, 2007.