Both products of AstraZeneca - Prilosec and Nexium - are members of a class of drugs known as proton pump inhibitors (PPIs) and are indicated for the treatment of severe gastroesophageal reflux disease (GERD).




Earlier this year, there was an issue raised on whether long term use of such drug can increase the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared to patients who received surgical treatment.

Since then, the FDA has conducted a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium, which when completed resulted to the following:

While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified.

As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging. FDA's assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled.

Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.

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.

Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems.

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.

By the way, Nexium (esomeprazole) is the newer formulation of the original Prilosec (omeprazole) product - both prescription drugs used to treat the symptoms of GERD and other conditions caused by excess stomach acid.

Source: FDA News

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