The FDA has recently completed a comprehensive review of the safety data for both Prilosec and Nexium. Recently, there have been concerns voiced in the media about the safety of these drugs. Often times, the media is quick to jump on a report that may suggest an issue with a pharmaceutical product, the reality of the situation is often much more complex and needs to be thoroughly reviewed before any assumptions are made or published.

From the FDA’s website (www.fda.gov) “FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium. 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.”