Prilosec, Nexium analysis shows no heart disease link

ROCKVILLE, Md. The Food and Drug Administration on Monday affirmed that long-term use of either of the proton-pump inhibitors Prilosec or Nexium was not linked to any increase in the risk of heart disease.

However, the FDA continues to explore a potential increased risk of hip fractures associated with the use of PPIs, FDA officials told reporters this afternoon during a press conference.

“FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium,” the agency stated. “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.”

The concern over a potential increased risk of heart disease and the use of these PPIs was raised earlier this year when AstraZeneca, manufacturer of both of these PPIs, reported a difference in the frequency of heart attacks and other heart-related problems out of earlier analyses of two small, long-term studies. FDA commissioned a formal safety review of the two drugs in August.

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