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No cardiovascular risk found in Prilosec/ Nexium says FDA

The FDA's review of clinical studies involving AstraZeneca's antacid drugs Nexium and Prilosec does not demonstrate an increase in heart attacks and sudden death

The FDA's review of clinical studies involving UK-headquartered AstraZeneca's (AZ) antacid drug Nexium (esomeprazole) and Prilosec (omeprazole) has not demonstrated an increase in heart attacks and sudden death.

Since May 2007, the FDA has been conducting a safety review of the drugs, which are approved to treat gastroesophageal reflux disease, when AZ submitted the results of two small, long-term studies that suggested the drug could increase the risk of heart problems and sudden death. Prilosec is also marketed in OTC versions in the US.

The FDA asked AZ to submit extra data about the drugs for review. The agency said its review of the two long-term studies, along with 14 additional studies, shows the products are "not likely to be associated with an increased risk of heart problems".

11th December 2007

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