FDA To Investigate Cardiac Risks Associated With Heartburn Drugs
FDA on Thursday announced that it will take three months to conduct an analysis of cardiac risks associated with AstraZeneca's heartburn drugs Prilosec and Nexium in response to two studies suggesting increased risk of heart attacks and heart failure for patients taking the drugs, the New York Times reports (Harris, New York Times, 8/10).
The agency said there is no concrete evidence of such risks. Both FDA and Health Canada said patients and doctors should continue to use and prescribe the drugs (AP/Long Island Newsday, 8/9).
The company on May 29 sent FDA the results of a 14-year study on Prilosec and an ongoing study on Nexium (New York Times, 8/10). The studies, which involve a few hundred patients with gastroesophogeal reflux disease, compare results of patients taking heartburn drugs with those undergoing surgery.
The Prilosec study showed that 17 patients taking the drug experienced serious heart problems, compared with eight in the surgery group. However, patients in the drug group appeared to be older and in poorer health before the study began, which could help explain the outcomes. Six patients in the Prilosec group had experienced previous heart attacks, compared with none in the surgery group (Alonso-Zaldivar, Los Angeles Times, 8/10).
The Nexium study initially showed similar risks to the Prilosec study, but the risks abated over time, according to FDA (New York Times, 8/10).
Fourteen other studies of the drugs have shown no increased heart risks, according to FDA, and some found that patients taking the drugs had a lower incidence of cardiac events than those taking a placebo (AP/Long Island Newsday, 8/9).
The agency said, "Based on everything we know now, FDA's preliminary conclusion is that the observed difference in risk of heart attacks and other heart-related problems seen in early analyses of the two small long-term studies is not a true effect." Prilosec and Nexium belong to a class of heartburn drugs known as proton pump inhibitors. FDA has requested safety information on all drugs of this class (New York Times, 8/10).
The announcement marks the agency's first alert issued in the form of an "Early Communication" concerning an ongoing safety review, part of an attempt to more quickly publicize potential health risks associated with drugs (Reichard, CQ HealthBeat, 8/9).
According to Paul Seligman, FDA associate center director for safety policy and communication, the announcement was the earliest public warning the agency has ever made during a safety review (New York Times, 8/10).