December 11, 2007
The FDA issued its final assessment of two small, open, long-term, clinical studies in patients with gastro-esophageal reflux disease, comparing anti-reflux surgery with either Prilosec (omeprazole) (SOPRAN study) or Nexium (LOTUS study) treatment. AstraZeneca 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 healthcare providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs." AstraZeneca also supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium.