FDA finds no evidence of increased cardiac events with Nexium or Prilosec.

FDA announced that it has completed a comprehensive, scientific review of known safety data for the proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), and concluded that the reported difference in the frequency of heart attacks and other heart-related problems seen in earlier analyses of the two small long-term studies does not indicate the presence of a true effect.

Therefore, FDA said in a statement, the agency "continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems."

On May 29, AstraZeneca, the maker of the two drugs for gastroesophageal reflux disease (GERD) sent FDA data from two long-term studies in patients with severe GERD that were being treated with either Prilosec or Nexium.

Participants were randomly assigned to receive treatment with either a drug (Prilosec in one study and Nexium in the other) or surgery. During the studies, cardiovascular events raised a question about whether long-term use of these drugs increases 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.

FDA released an Early Communication of an Ongoing Safety Review of these drugs in August. The agency's initial review determined that there was no in creased risk of heart problems associated with long-term use of these drugs. At FDA's request, AstraZeneca submitted a large amount of additional information about these and other studies and FDA undertook a comprehensive review of all available data regarding this potential safety concern.

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, FDA said, "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."

To read a summary of what FDA knows about the data, visit:

www.fda.gov/cder/drug/early_comm/omeprazole_eso mepazole_update.htm.

To read the Early Communication visit: www.fda.gov/cder/drug/early_comm/omeprazole_eso meprazole.htm.