ST LOUIS (MD Consult) - On May 25, 2010, The US Food and Drug Administration (FDA) announced revisions being made to the labels for prescription and over-the-counter (OTC) proton pump inhibitors (PPIs). These changes reflect new safety information about a possible increased risk for fractures of the hip, wrist, and spine with use of these drugs. Medications referred to in this announcement include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex , Vimovo, Prilosec OTC, Zegerid OTC, and Prevacid 24HR.

Proton pump inhibitors are used to treat conditions such as frequent heartburn, gastroesophageal reflux disease, gastric and intestinal ulcers, and esophageal inflammation.

The need for inclusion of new safety information on the labels for PPIs was determined on the basis of results from an FDA review of several epidemiologic studies that reported an increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use. Some studies found that persons at greatest risk for these fractures took PPIs for at least 1 year or received high PPI doses. The majority of the studies evaluated persons aged 50 years or older and the increased risk of fracture primarily was observed in this age group. However, the exact mechanisms for an increased risk of fractures with PPI use cannot be determined at this time. Several limitations in the epidemiologic studies were found to exist. Results from 3 epidemiologic studies found no consistent association between chronic PPI use and bone mineral density.

To further investigate this issue, the FDA plans to analyze data from several large, long-term, placebo-controlled clinical trials that involved the use of bisphosphonates. The FDA hopes to be able to assess the risk of fractures in women in these studies who were at risk for osteoporosis-related fractures and who received or did not receive PPIs. In addition, the FDA is working with PPI manufacturers to further study this possible risk.

Health care professionals and consumers are being advised to weigh the known benefits against the potential risks of PPI use. When recommending treatment with PPIs, clinicians should consider whether a lower dose or shorter duration of therapy would adequately treat a patient's condition.

Consumers are advised to be aware that OTC PPIs should only be used as directed for 14 days for the treatment of frequent heartburn, and that no more than three 14-day treatment courses should be used in 1 year.