FDA review of omeprazole and esomeprazole
admin December 12th, 2007
The FDA has completed its review of the safety of omeprazole and esomeprazole, in the wake of two studies that appeared to show higher rates of cardiac events in those treated with the proton pump inhibitors (PPIs). Both of these studies were small, one had differences in the baseline cardivascular status of the subjects, and both studies failed to adaquately define or verify heart problems, such as heart attacks making evaluations of the safety of either drug in these studies difficult. FDA analysis of 14 other studies of omeprazole showed no apparent increase in the risk of cardiovascular adverse drug reactions.
Bottom line: The FDA analysis seems to discount fears of potential adverse cardiovascular effects of PPIs. Prescribers should be reassured that such drugs can be prescribed in those with cardiovascular disease, especially considering that they are commonly co-prescribed with aspirin in order to reduce the risks of gastrointestinal bleeding.
- FDA
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