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Tuesday, December 11, 2007

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n a prepared statement released earlier in the day, the FDA also said: "Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect."

And it added, "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."

Dr. Paul O. Katz, chairman of gastroenterology at Albert Einstein Medical Center in Philadelphia, agreed that these drugs are safe and that patients shouldn't hesitate to use them.

"This is altogether good news," Katz said. "It is reassuring to physicians and the public, who are using these drugs on a widespread basis, that this is not deemed to be an issue."

Both drugs are made by the British pharmaceutical company AstraZeneca. In May, the company gave the FDA findings from two small, preliminary trials that were designed to test the effectiveness of the drugs, compared with surgery, for severe gastroesophageal reflux disease (GERD).

During the trials, some cardiac "events" were seen among study participants, hinting that long-term use of Prilosec and Nexium could increase the risk of heart attack, heart failure and heart-related sudden death, the FDA said at the time.

Because of these concerns, AstraZeneca gave the FDA more detailed data from the two initial studies as well as findings from 14 other studies -- one 14 years in length -- that compared the drugs with a placebo.

The more complete data showed that patients taking Prilosec had a lower risk of heart problems than patients taking a placebo. And findings from the ongoing Nexium trial found no difference in heart problems between patients taking the drug and those undergoing surgery for GERD, the FDA statement said.

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