Tuesday, December 11, 2007

FDA: No increase in heart trouble from Prilosec and Nexium

On May 29, 2007 AstraZeneca, the maker of Prilosec and Nexium, sent the FDA data from studies that AstraZeneca had conducted. Cardiovascular events raised a question about whether long-term use of Prilosec and Nexium increased the risk of heart attacks, heart failure, and heart-related sudden death.

Anyone that has had any connection to these drugs will likely recall the issuance in early August of the FDA's ongoing safety review of the drugs. This review was conducted with the assistance of AstraZeneca and included 14 comparative studies of Prilosec - four of which were placebo-controlled.

In a press release issued December 10, 2007 the FDA stated that the heartburn drugs Prilosec and Nexium have been determined to not present increased heart risks. The FDA concluded that long-term use of the two drugs was not likely to be associated with an increased risk of heart problems, stating: "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."

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