Advice from FDA: Possible Increased Risk of Bone Fractures With Certain Antacid Drugs


Proton pump inhibitors (PPIs) are medicines that work to decrease the amount of acid in the stomach. They are available both as prescription and as over-the-counter medicines. Prescription PPIs treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.

Recently, the Food and Drug Administration (FDA) reviewed seven published studies on PPIs. The results of six of the studies showed an increased risk of fractures of the hip, wrist, and spine with the use of PPIs. This was most commonly seen in people 50 years of age or older. It is not clear if PPI use is the direct cause of this in-creased risk. FDA is working with the manufacturers of PPIs to further study this possible risk.

As a precaution, FDA is revising the labels for both the over-the-counter and the prescription PPIs. The labels will include new safety information about the possible increased risk of fractures of the hip, wrist, and spine with the use of these medicines.

The prescription PPIs are:

  • Nexium (esomeprazole)
  • Dexilant (dexlansoprazole)
  • Prilosec (omeprazole)
  • Zegerid (omeprazole and sodium bicarbonate)
  • Prevacid (lansoprazole)
  • Protonix (pantoprazole)
  • Aciphex (rabeprazole)
  • Vimovo (naproxen and esomeprazole)

 The over-the-counter PPIs are:

  • Prilosec OTC (omeprazole)
  • Zegerid OTC (omeprazole and sodium bicarbonate)
  • Prevacid 24 HR (lansoprazole)

 è Here’s what you can do: Do not stop taking your prescription PPI unless you are told to do so by your doctor. There is an increased risk of fractures in those taking higher doses of these medicines or if they are used for a year or longer. Discuss your options with your doctor.

Talk to your doctor before taking an over-the-counter PPI. Read and follow the directions on the label. Over-the-counter PPIs should only be used for 14 days to treat frequent heartburn. If your heartburn continues after 14 days of taking the PPI, notify your doctor. No more than three 14-day treatment courses should be used in one year. If you have any questions or concerns, talk to your doctor or pharmacist.

Advice from FDA is a feature brought to you by the US Food and Drug Administration (FDA). You can find this article and more on FDA’s Consumer Health Information website .

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Created on March 2, 2011