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New research suggests that users of popular heart burn drugs, such as Nexium and Prilosec, may face an increased risk of heart attacks.
In a study published last week in the science journal PLOS One, researchers from Stanford University indicated that use of drugs that are part of a class of antacids known as proton pump inhibitors were 20% more likely to suffer a heart attack.
PPIs reduce the amount of acid in the stomach and are used to treat gastroesophageal reflux disease (GERD), as well as heartburn, ulcers in the stomach and small intestines, as well as inflammation of the esophagus. Drugs that belong to the class include blockbuster treatments like Nexium, Prevacid, Prilosec (and generic omeprazole), Protonix, AcipHex, Dexilant, Vimovo and Zegerid.
Nexium is the most widely used medication from this class, generating an estimated $6 billion in annual sales before it became available over-the-counter and as a generic.
In the study, researchers data mined clinical information from 16 million documents on nearly 3 million patients, looking for an association between PPI use and cardiovascular risk.
The research was prompted after a number of previous studies found poor clinical outcomes among patients who took both Plavix and a PPI after acute coronary syndrome. Other data also suggested that PPIs may be linked to a risk among people who had no prior history of cardiovascular disease.
In addition to an increased risk of heart attack, researchers found that taking PPIs doubled the risk of patients dying of heart problems. They found that risk existed regardless of whether the patient took Plavix.
“The current study suggests that the risk of PPIs may extend beyond previously studied high risk individuals,” the researchers concluded. “These findings, in conjunction with the preclinical results, necessitate additional investigation.”
Heart burn drugs have already been linked to a number of potentially harmful side effects, and some consumer watchdog groups have even warned that they could be addictive. One of the most dramatic side effects are those of bone fractures.
In 2010, the FDA required the manufacturers of all other proton pump inhibitor (PPI) medications to update the warning labels, adding information about a potential risk of fractures and bone problems from side effects of Prilosec, Nexium and other drugs in the same class.
That warning was updated again by the FDA in 2011, indicating that the risk of broken bones from Nexium appears to be linked to high doses of the medication used over long periods of time, which is exactly the kind of prescribing behavior the study found happens far too often. Over-the-counter versions of the drug did not appear to be affected, according to federal drug regulators.
A number of former users who have suffered bone fractures have pursued a Nexium lawsuit, alleging that AstraZeneca failed to adequately warn about the risks associated with long term use of the heartburn drug.