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FDA Warns of Fracture Risk From Acid Reflux Drugs
PPI Antacids Linked to Hip, Wrist, and Spine Fracture
By Daniel J. DeNoon
WebMD Health News
Reviewed by Laura J. Martin, MD
May 25, 2010 -- Popular PPI antacids -- Aciphex, Dexilant, Nexium, Prevacid, Prilosec, Protonix, Vimovo, and Zegerid -- raise the risk of bone fracture, especially when used for a year or more or at high doses, the FDA warns.
The warning comes after U.S. and Canadian researchers linked the use of PPIs (proton pump inhibitors) to fracture risk in middle-aged adults. Another U.S. study suggests that the drugs may also increase risk of infection with C. difficile, a bacterium that can cause severe diarrhea.
"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 FDA today warned consumers.
The action follows FDA review of six studies that link PPIs to fractures, although the studies do not definitively prove that PPIs are the cause of the fractures seen in the studies.
Most of the increased fracture risk is seen in people over age 50.
The federal agency will now require the warning to be added to the package labels of both the prescription and nonprescription versions of the drugs.
The drugs all are proton pump inhibitors (PPIs), the most powerful class of antacid drugs. It's the third highest-selling class of drugs in the U.S. Each year, doctors write 113.4 million prescriptions for the drugs. Three -- Prevacid, Prilosec, and Zegerid -- are available without prescription.
The drugs do a great job of reducing stomach acid. They're not only far more powerful than simple antacids (such as Maalox, Rolaids, and Tums) but also reduce stomach acid more than the H2RA drugs Axid, Pepcid, Tagamet, and Zantac.
These powerful drugs are supposed to be used only for serious conditions, but often are taken for simple heartburn. There's no doubt they're effective, but the benefit for minor conditions may not be worth the risk.
The FDA offers the following advice to patients:
If you are currently taking prescription medication for your symptoms and are interested in building more health and perhaps getting off your medication by addressing the cause of your health concern, please call the office and let us discuss your options. I will work with your medical doctor to restore your health and reduce or eliminate the need for medication.
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