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FDA Finds No Increased Heart Risk From Prilosec, Nexium

Heartburn drugs safe to use, agency finds

December 10, 2007

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The U.S. Food and Drug Administration says it can find no evidence that two popular acid reflux medications, Prilosec and Nexium, lead to increased risk of heart trouble. The agency’s final assessment was based on two clinical studies of patients with the disease.

“On May 29, 2007 AstraZeneca, the maker of Prilosec and Nexium, sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) that were being treated with either Prilosec or Nexium,” the FDA said in a statement.

“During the studies, cardiovascular events raised a question about whether long-term use of these drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared to patients who received surgical treatment.”

In August the FDA released an "Early Communication of an Ongoing Safety Review" of these drugs, initially finding that there was no increased risk of heart problems associated with long-term use of these drugs. At FDA’s request, AstraZeneca submitted a large amount of additional information about these and other studies and FDA undertook a comprehensive review of all available data regarding this potential safety concern.

The FDA said it has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium.

While both of the long-term studies reported to FDA in May collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified. As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging, the agency admits.

FDA said its assessment was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.

“Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect,” the FDA concluded.

Therefore, FDA said it stands by its earlier position that long-term use of these drugs is not likely to be associated with an increased risk of heart problems.

“FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs,” the statement said.

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