Prescription, OTC proton heartburn meds linked to wrist, hip, spine fractures

posted on:
May 26, 2010


Taking certain drugs to treat symptoms of heartburn, acid reflux or ulcers may increase your risk of hip, wrist and spine fractures, warns the Food and Drug Administration (FDA). The drugs belong to a class of medications called proton pump inhibitors, or PPIs, which work by reducing the amount of acid in the stomach. The drugs are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus, and over-the-counter to treat frequent heartburn.

Prescription PPIs are:

  • Nexium
  • Dexilant
  • Prilosec
  • Zegerid
  • Prevacid
  • Protonix
  • Aciphex
  • Vimovo

Over-the-counter PPIs are:

  • Prilosec OTC (omeprazole)
  • Zegerid OTC (omeprazole)
  • Prevacid 24HR (lansoprazole)

The FDA has found, based on a review of several epidemiological studies, that consumers who received high doses of PPIs or used them for one year or more were at greater risk for wrist, hip and spine fractures. The majority of studies evaluated individuals 50 years of age or older; the increased risk of fracture primarily was observed in this age group.

It is not clear whether the use of PPIs is the cause of the increased risk in fractures, however the FDA says it will work with the manufacturers of PPIs to further study this possible risk. In the meantime, as a precaution, the “Drug Facts” label on both the prescription PPIs and the OTC varieties, which are indicated for 14 days of continuous use, are being revised to include information about this risk.

Consumers are advised not to stop taking PPIs unless told to do so by their health care professional. They should also be aware that OTC PPIs should only be used as directed for 14 days for the treatment of frequent heartburn. No more than three 14-day treatment courses should be used in one year. Any questions or concerns about PPIs should be directed to a health care professional.

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