Analysis of PPI cardiovascular risk encouraging

December 12, 2007

FDA says long-term PPI use does not pose cardiovascular risk

A comprehensive evaluation of safety data for long-term omeprazole and esomeprazole therapy does not show an increased risk of cardiovascular (CV) events including heart attack, heart failure, and heart-related sudden death. The analysis performed by the FDA, included review of two long-term studies of the drugs in patients with severe gastroesophageal reflux disease (GERD), other information from manufacturer AstraZeneca, and 14 other comparative studies of omeprazole. Although the studies were not designed to assess CV safety, the findings show the drugs are not likely to be associated with an increased risk of heart problems. The FDA has posted a summary of its findings at www.fda.gov/cder/drug/early_comm/omeprazole_esomepazole_update.htm.

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