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FDA Says Heartburn Drugs May Carry Fracture Risk

May 26, 2010 | Parker Waichman LLP Proton pump inhibitors, a class of heart burn drugs that includes Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex, may increase the risk of fractures, according to the Food & Drug Administration (FDA). Labeling for these medications will be changed to describe this possible side effect.

Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount of acid in the stomach. Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

OTC versions, used for the treatment of frequent heartburn, include Prilosec OTC, Zegerid OTC and Prevacid 24HR.

The new safety information is based on the FDA’s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use. Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group.

While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk, the FDA said.

Based on the available data, the agency said at this time it is not clear if the use of proton pump inhibitors is the cause of the increased risk of fractures seen in some epidemiologic studies.

To further investigate this issue, the FDA plans to analyze data from several large, long-term, placebo-controlled clinical trials of bisphosphonates (drugs used to prevent fractures) to assess the risk of fractures in women at risk for osteoporosis-related fractures who used or did not use proton pump inhibitors. The FDA is also working with the manufacturers of these products to further study this possible risk.

The FDA is advising that healthcare professionals and users of proton pump inhibitors be aware of the possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors, and weigh the known benefits against the potential risks when deciding to use them.

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