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FDA: No increased cardiovascular risk with heartburn drugs
The FDA recommends continued use and prescription, despite ongoing safety review.
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September 2007
Results from two studies submitted to the FDA in late-May suggested an increased cardiovascular risk with long-term use of the popular heartburn drugs omeprazole and esomeprazole.
However, after a preliminary safety review of the drugs, the FDA found no increased risk.
“Therefore, the FDA does not believe that health care providers or patients should change either their prescribing practices or their use of products at this time,” according to a press release issued by the FDA.
Omeprazole (Prilosec, AstraZeneca) and esomeprazole (Nexium, AstraZeneca) are proton pump inhibitors. The drugs help reduce the amount of acid in the stomach to treat gastroesophageal reflux disease and ulcers. Both drugs are commonly used and available by prescription; omeprazole is also available over-the-counter.
Preliminary conclusion
In both of the studies AstraZeneca submitted to the FDA, patients were randomly assigned to receive either omeprazole or esomeprazole or to undergo surgery to control gastroesophageal reflux disease.
The researchers from one study, which was conducted for 14 years, compared omeprazole with gastroesophageal reflux surgery. There were more reports of MI, HF and cardiovascular-related death in patients treated with omeprazole compared with patients who underwent the surgery. In the second ongoing study researchers compared esomeprazole with surgery. Five-year follow-up data indicated similar results.
The FDA also analyzed 14 other comparative studies. However, in these studies there were fewer reported MIs and cardiovascular complications among patients treated with the heartburn drugs compared with placebo.
Thus, the FDA’s “preliminary conclusion is that the observed difference in risk for MI and other heart-related problems seen in early analyses of the two small, long-term studies is not a true effect,” the agency said.
A complete review
“This information reflects the FDA’s current analysis of available data concerning these drugs,” the agency wrote. “This does not mean that the FDA has concluded there is a causal relationship between the drug products and the emerging safety issue.”
FDA officials noted several limitations with the preliminary review and the submitted study data. Nonspecified protocols and younger, healthier patients randomly assigned to undergo surgery may have influenced the safety data.
The FDA plans to complete the safety data review within three months.
Pending the complete review, patients should not stop or change their medication in lieu of this preliminary conclusion, according to the FDA.