Fracture risk may increase with high-dose long-term use of PPIs

August 1, 2010

The US Food and Drug Administration has issued a warning that high doses and/or long-term use of prescription or over-the-counter proton pump inhibitors may increase risk for fractures of the hip, waist and spine.

The US Food and Drug Administration (FDA) has issued a warning that high doses and/or long-term use (1 year or longer) of prescription or over-the-counter (OTC) proton pump inhibitors (PPIs) may increase the risk for fractures of the hip, wrist, and spine.

The FDA safety announcement was issued after a review of 7 published epidemiologic studies that used claims data from computerized administrative databases to compare the risk of fractures of the hip, wrist, and spine in persons taking PPIs against those not taking the drugs.

As a result, the agency has mandated that manufacturers of these drugs, used in treating gastroesophageal reflux disease, ulcers of the stomach and small intestine, and esophageal inflammation, revise both the warnings and precautions sections of prescription labels and the drug facts section of OTC product labels to include explanation of the increased risk of fracture.

Over-the-counter products affected include omeprazole (Prilosec OTC, Zegrid OTC) and lansoprazole (Prevacid 24 HR).

Physicians are advised to be aware of the increased fracture risk associated with long-term use and high doses of PPIs and weigh the known benefits of these drugs with their potential risks before prescribing them.

US Food and Drug Administration. FDA drug safety communication: possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors [safety announcement]. http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm213206.htm. Accessed July 16, 2010.