FDA issues labeling change for OTC proton pump inhibitors

April 5, 2011

The risk of fracture is unlikely in patients taking short-term, low-dose proton pump inhibitors, according to a review of available safety data by FDA.

The risk of fracture is unlikely in patients taking short-term, low-dose proton pump inhibitors (PPIs), according to a review of available safety data by FDA. Consequently, FDA has determined that an osteoporosis and fracture warning on the over-the-counter (OTC) PPI medication "Drug Facts" label is not indicated at this time.

In May 2010, FDA notified healthcare professionals that labels for prescription and OTC PPIs would include new safety information about the possible increased risk of hip, wrist, and spine fractures with use of these medications. Several epidemiological studies found the risk for fractures was elevated in patients aged 50 years or older. The greatest risk occurred in those taking PPIs for at least 1 year or who had been taking high doses of prescription PPIs (not available OTC).

FDA, as a precaution, revised the "Drug Facts" label on the OTC PPI (indicated for 14 days of continuous use) to include information about the fracture risk. Healthcare professionals were advised by FDA to consider prescribing a lower dose or shorter duration of therapy for patients taking PPIs.

The class labeling change, issued by FDA on March 22, 2011, applies to Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, Vimovo, Prilosec OTC, Zegerid OTC, and Prevacid 24HR.