The FDA has notified healthcare professionals and patients of labeling changes for prescription and over-the-counter (OTC) proton pump inhibitors (PPIs) to include new safety information about a possible increased risk of fractures with the use of these medications. The new safety information is based on the FDA’s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with PPI use. Some studies found that those at greatest risk for these fractures received high doses of PPIs or used them for one year or more. The majority of the studies evaluated individuals ≥50 years of age and the increased risk of fracture primarily was observed in this age group. As a precaution, the “Drug Facts” labels for the OTC PPIs are being revised to include information about this risk.
Proton pump inhibitors are indicated for the treatment of gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, inflammation of the esophagus, and frequent heartburn. The FDA recommends that healthcare professionals, when prescribing PPIs, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition. Proton pump inhibitors include Aciphex (rabeprazole, from PriCara), Dexilant (dexlansoprazole, from Takeda), Nexium (esomeprazole, from AstraZeneca), Prevacid (lansoprazole, from Takeda), Prevacid 24HR (lansoprazole, from Novartis Consumer Health), Prilosec (omeprazole, from AstraZeneca), Prilosec OTC (omeprazole, from Procter & Gamble), Protonix (pantoprazole, from Wyeth), Vimovo (naproxen and esomeprazole, from AstraZeneca and POZEN), Zegerid (omeprazole and sodium bicarbonate, from Santarus), and Zegerid OTC (omeprazole and sodium bicarbonate, from Schering-Plough Healthcare).
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213321.htm.