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Nexium, Prilosec: No Heart Risks Seen

FDA Review Shows No Risk of Heart Attack, Heart Failure, or Heart-Related Sudden Death

Prilosec, Nexium Data continued...

In the Prilosec study, more patients treated with Prilosec had heart attacks, heart failure, and heart-related sudden death than did the patients who had surgery. The difference between the two groups of patients was seen within the first year of the study, and continued over time.

In the ongoing Nexium study, initial data from this study suggested a difference between treatments in the rate of cardiovascular events. But an updated report submitted by AstraZeneca found that the number of patients who experienced heart problems was similar in both treatment groups.

No Heart Risk Seen

While both studies collected safety data, they didn't specify how heart problems, such as heart attacks, were to be defined or documented. As a result, the FDA says evaluating the information that has been gathered about the safety of either drug in these studies is difficult.

Since May 29, AstraZeneca has provided the FDA with a large amount of additional data from the two trials, along with pooled analyses of other studies.

At this point, the FDA's initial review of that data doesn't suggest an increased risk of heart problems for patients treated with Prilosec or Nexium.

Seligman notes that while the review isn't complete, the FDA issued today's statement as part of its commitment to inform health care providers and patients about emerging safety issues that affect public health.

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