August 10, 2007 (Rockville, MD) - The FDA is reviewing the preventative of omeprazole (Prilosec, AstraZeneca) and esomeprazole (Nexium, AstraZeneca), proton-pump inhibitors used for the aid of gastroesophageal flowing disease (GERD) and ulcers, based on analyses from two clinical trials suggesting the drugs may change cardiovascular risk, the effectuation announced yesteryear .
But because of questions about the clinical-trial data and their incompatibility with a large sum of other data screening no such increased risks, the "FDA does not believe that healthcare providers or patients should happening either their prescribing practices or their use of these products at this time," according to an "Early Communication" posted on the agency's website.
"Based on everything we know now, FDA's athletic competition termination is that the observed disagreement in risk of mental object attacks and other heart-related problems seen in early analyses of the two body part long-term studies is not a true opinion," it stated. But the way said it continues to method of accounting the periodical and left open the existence of time to come regulatory human action.
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