FDA: Fracture Risk with Stomach Acid Drugs

WASHINGTON, May 25 (UPI) — The U.S. Food and Drug Administration issued a warning Tuesday about a possible increased risk of fractures when using stomach acid inhibitors.

The FDA said the increased risk of hip, wrist and spine fractures has been associated with high doses or long-term use of a class of medications called proton pump inhibitors.


The drugs, available by prescription and over-the-counter, reduce the amount of acid in the stomach. Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix) and rabeprazole (Aciphex). Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease, also known as GERD; stomach and small intestine ulcers; and inflammation of the esophagus.

Over-the-counter proton pump inhibitors include Prilosec, Zegerid and Prevacid.

“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, healthcare professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”

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