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.
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 your doctor recommended that you take a PPI, don't stop taking the medication until you discuss it with him or her.
- The greatest risk from PPIs is among people who take high doses or remain on the drugs for a year or more.
- Over-the-counter PPIs should be taken for only 14 days for treatment of frequent heartburn. No more than three 14-day courses should be taken in a single year.
- Discuss any concerns you may have about taking PPIs with your doctor.
- Report any possible PPI side effects to the FDA either online or by phone at (800) 332-1088.