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AstraZeneca

FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated with omeprazole and NEXIUM(R) (esomeprazole magnesium)

Published in Medical Letter on the CDC and FDA, December 30th, 2007

The US Food and Drug Administration (FDA) issued its final assessment of two small, open, long-term, clinical studies in patients with gastro-esophageal reflux disease (GERD), comparing anti-reflux surgery with either omeprazole (SOPRAN study) or NEXIUM(R) (LOTUS study) treatment.

AstraZeneca (NYSE:AZN) agrees with the FDA conclusion which states "FDA continues to conclude 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." AstraZeneca also supports the...

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