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PPIs heart safe

This article was originally published in The Tan Sheet

Executive Summary

Use of AstraZeneca's proton-pump inhibitor Prilosec (omeprazole) or the follow-on Nexium (esomeprazole) does not increase the risk of cardiovascular events, according to a Dec. 10 statement by FDA. The administration assessed two small, long-term studies on Prilosec and Nexium reported earlier this year - both of which had raised a question as to whether long-term use of the drugs increased the number of heart attacks, heart failures and heart-related sudden death - as well as 14 comparative studies of Prilosec, four of which were placebo-controlled. FDA announced in August that it was conducting the greater review of safety data but based on preliminary data, health-care providers and patients should not change their prescribing or use practices, respectively (1"The Tan Sheet" Aug. 13, 2007, p. 3). Based on the now complete comprehensive, scientific review, FDA concluded that the frequency of cardiovascular events seen in the earlier analyses does not indicate the presence of a true effect...

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