News | December 10, 2007

FDA Finds No Evidence of Increased Rates of Cardiac Events with Prilosec, Nexium

December 11, 2007 - The FDA issued its final assessment of two long-term studies in patients with severe gastroesophageal reflux disease (GERD) who were being treated with either Prilosec or Nexium, and finds that “long-term use of these drugs is not likely to be associated with increased risk of heart problems.”

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. At the FDA’s request, AstraZeneca submitted a large amount of additional information about these and other studies and the agency undertook a comprehensive review of all available data regarding this potential safety concern.

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 recommends that healthcare providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.

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