Safety Alerts & Recalls

What does this mean?

The FDA is revising the prescription and over-the-counter (OTC) labels for the PPIs to include this new safety information about the possible increased risk of fractures of the hip, wrist, and spine with the use of these medications. If you take a PPI, you may wish to review this safety information with your doctor or other healthcare professional at your next appointment, especially if you have been using a prescription PPI for more than a year.

The FDA provides the following advice to patients who take PPIs:

1) PPIs are effective in treating a variety of gastrointestinal disorders. Do not stop taking your PPI unless told to do so by your healthcare professional.

2) Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of patients using PPIs. The greatest increased risk for these fractures was seen in patients who receive high doses of these medications or use them longer (a year or more).

3) Read and follow the directions on the "Drug Facts" label, when considering use of over-the-counter PPI.

4) Be aware that the over-the-counter PPIs should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your healthcare professional. No more than three 14-day treatment courses should be used in one year.

5) Talk to your healthcare professional about any concerns you may have about using PPIs.

FDA Updates Prescribing Information for Proton Pump Inhibitors to Warn About Increased Risk of Fractures

The U.S. Food and Drug Adminstration (FDA) has announced there is a possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers. The drugs belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach. This new safety information is based on the FDA's review of several studies that reported an increased risk of fractures of the hip, wrist, and spine with PPI use. The greatest increased risk for fractures in these studies involved people who had been taking prescription PPIs for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter).

This FDA review included the Archives of Internal Medicine study described in the recent iGuard alert about this same safety issue.

PPIs are available both as prescription and as over-the-counter (OTC) medications. The prescription PPIs treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus. The PPIs available over-the-counter are used to treat frequent heartburn. The prescription PPIs are esomeprazole (Nexium), dexlansoprazole (Dexilant), lansoprazole (Prevacid), omeprazole (Prilosec), omeprazole and sodium Bicarbonate (Zegerid), pantoprazole (Protonix), rabeprazole (Aciphex), and naproxen and esomeprazole (Vimovo). Prilosec OTC, Prevacid 24HR, and Zegerid OTC are sold over-the-counter (OTC) for the treatment of frequent heartburn.

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Source: FDA
Publication Date: 2010-05-26
Last Updated: 2010-05-26
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