Proton Pump Inhibitors (PPIs)

The FDA is revising the prescription and over-the-counter (OTC) labels for proton pump inhibitors to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies. Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. As a precaution, the "Drug Facts" label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk.

Healthcare professionals should be aware of the possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors, and when prescribing, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

Return to FDA Drug Info Rounds Page