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Korean researchers indicate they have conducted a study that provides further evidence that side effects of some popular heartburn drugs, such as Nexium, Prilosec and Prevacid, may increase the risk of bone fractures.
According to new research published in the latest issue of the Annals of Family Medicine, researchers from the Department of Family Medicine at Hallym University Hospital in Chuncheon, Korea have found that a class of acid-suppressive heartburn drugs known as proton pump inhibitors (PPIs) are associated with nearly a 30% increase in the risk of bone fractures.
The researchers conducted a meta-analysis of a number of observational studies, looking at both PPIs, which include Nexium, Prevacid, Prilosec, Protonix, Aciphex, Vimovo and Zegerid, and a class of drugs known as histamine 2 receptor antagonists (H2RAs) that includes Zantac and Pepsid. The PPIs were associated with a significantly increased risk of bone fracture, the researchers determined, while the H2RAs were not.
The overall risk of a bone fracture from Nexium, Prilosec or similar drugs was 29% higher than normal. However, the increased risk of a hip fracture was 31% higher than normal, and the risk of suffering a vertebral fracture was 54% higher.
The findings come almost a year after the FDA issued a bone fracture warning for PPIs and required new warnings of bone fracture risk be added to their labels. The FDA updated that warning in March, saying that the bone fracture risk appeared to be dose-specific and limited to prescription-strength versions of the drugs.
The prescription drugs pull in about $14 billion in U.S. sales each year, and many are prescribed for indigestion and heart burn, although with the exception of Prilosec, they are only approved for treatment of ulcers, acid reflux disease and erosive esophagitis. There were about 119 million prescriptions for proton pump inhibitors in the U.S. last year. Some medical experts estimate that as many as 69% of proton pump inhibitor prescriptions were written for “off-label” uses, which have not been approved as safe and effective by the FDA.