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FDA ruling on AZ antacids expected soon

The FDA is poised to update on any potential heart risks of AstraZeneca's blockbuster antacid drugs, Nexium and Prilosec, which are used by over one billion people globally

According to local media reports, the FDA is poised to update on any potential heart risks of UK-based pharmaceutical company AstraZeneca's (AZ) antacid drugs, used by over one billion people globally.

In August 2007, the FDA and Health Canada revealed they were studying the cardiac impact of Prilosec (omeprazole) and Nexium (esomeprazole).

Both agencies cited two studies revealing a greater risk of heart attacks, heart failure and heart-related sudden death when compared with surgery. The FDA's own initial analyses did not show a higher heart risk, however, and both agencies have informed doctors not to change prescribing practices.

The "early communication" is part of a new FDA effort to notify the public and doctors sooner about potential drug risks in the face of recent criticism over its safety record with regards to GlaxoSmithKline's diabetes drug Avandia (roseglitazone) and Merck & Co's painkiller Vioxx (rofecoxib).

Nexium is AZ's top-selling product and was the world second best-selling drug in the world in 2006, according IMS Health data. Total global sales for Nexium in FY06 were USD 5.2bn.

A spokesperson for the American Gastroenterology Association said that patients normally exhibited two problems: a need for a Prilosec-type drug and heart disease. Both, he said, were very common, and the fact that they occasionally occur together was unsurprising.

The FDA has said both studies in question may have been skewed, in part because surgical patients tended to be younger and less likely to have risk factors for heart problems.

Fourteen other studies of patients treated for up to two years did not suggest a higher risk of heart problems with Prilosec, the FDA concluded.

6th December 2007

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