UPDATE: However, FDA officials revealed a separate agency review of hip fracture risk potentially associated with the class of drugs to which Nexium and Prilosec belong, Reuters writes. A year ago, the Journal of the American Medical Association reported on a study suggesting that long-term use of proton pump inhibitors increases the risk of hip fractures in adults over 50. "Internally we've looked at the issue and we've asked the sponsors to send additional information and analysis," said Joyce Korvick, deputy director in the gastroenterology unit at FDA. "That is under review."
Cardiovascular events, meanwhile, raised a question about whether long-term use of the drugs increases the risk of heart attacks, heart failure, and heart-related sudden death. In August, the FDA released an initial review that there was no increased risk of heart problems associated with long-term use. But at the agencyâ€™s request, AstraZeneca submitted additional info about these and other studies for a comprehensive review of all available data. The agency says the review was "challenging," given that the study protocols didn't specify how heart problems were defined or verified. But the agency says its findings were supported by 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," the FDA says.
"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," an FDA statement says.