FDA: Some heartburn meds pose long-term fracture risk
December 31st, 2016
Some heartburn medications could increase the risk of hip, wrist and spine fractures in high doses or with long-term use, the Food and Drug Administration warned.
Such so-called proton pump inhibitors are used for the treatment of gastroesophageal reflux disease, stomach and small intestine ulcers and inflammation of the esophagus, along with frequent heartburn.
They include esomeprazole, sold under the brand name Nexium, dexlansoprazole (Dexilant). lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix) and rabeprazole (Aciphex). Over-the-counter versions include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).
The product labeling will be changed to describe the possible increased risk, the FDA said in a statement Tuesday.
"Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses," said Dr. Joyce Korvick, deputy director for safety in FDA's Division of Gastroenterology Products.
"Because these products are used by a great number of people, it's important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition."
The warning and revised labeling stems from the FDA's review of several studies that reported an increased risk of hip, wrist and spine fractures in people using proton pump inhibitors. The warnings and precaution sections of prescription labels and the drug facts label on over-the-counter medications will address the findings, the agency said.
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