FDA warns providers, patients of increased fracture risk with proton pump inhibitors

The FDA warned health care professionals and patients of an increased risk for hip, spine and wrist fractures associated with high doses or chronic use of proton pump inhibitors — commonly used to reduce stomach acid.

In the May 25 announcement, the FDA said it is revising the labeling for over-the-counter (OTC) and prescription proton pump inhibitors (PPI) to include new safety information about the possibly increased fracture risk. FDA officials learned about the possibly greater risk for hip, spine and wrist fractures with PPIs from a review of seven epidemiological studies that reported greater risks for fracture with using the drugs for one or more years.

Possible increased risk

“Epidemiological studies suggest a possible increased risk for bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” Joyce Korvick, MD, deputy director for safety in the FDA Division of Gastroenterology Products, said in a press release. “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.”

OTC PPIs are frequently used to manage heartburn; they include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24 HR).

The various PPIs available by prescription include esomeprazole (Nexium), omeprazole (Prilosec, Zegerid) and rabeprazole (Aciphex), which health care professionals may prescribe to treat gastroesophageal reflux disease or GERD, stomach and small intestine ulcers, and inflammation of the esophagus.

Labeling changes

The changed Warnings and Precautions section of the drugs’ labeling will reflect findings from the epidemiological studies, according to the release. The FDA urged health care professionals and consumers to weigh the known benefits of PPIs against the potential risks when determining if these medications are appropriate for treatment.

In the warning, the FDA said it plans to conduct further investigations to determine if the PPIs actually caused the increased fracture risk and analyze data from large-scale, controlled bisphosphonate trials to assess the fracture risk in women taking them, with or without PPIs.

The agency said it is also working with manufacturers of these drugs to further assess the situation.

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