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U.S. Department of Health and Human Services

Safety

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Proton Pump Inibitor September Label Changes

  • Aciphex (rabeprazole sodium) delayed-release tablets
  • Dexilant (dexlansoprazole) delayed release capsules
  • Nexium (esomeprazole magnesium) delayed-release capsule and oral suspension
  • Nexium I.V. (esomeprazole sodium) for injection
  • Prevacid (lansoprazole) delayed-release capsules and orally disintegrating tablets
  • Prilosec (omeprazole magnesium) delayed release capsules and oral suspension
  • Protonix (pantoprazole sodium) for injection, delayed-release tablets, and oral suspension
  • Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules
  • Zegerid with Magnesium Hydroxide(omeprazole/sodium bicarbonate/magnesium hydroxide) chewable tablets and tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

 

Summary View

WARNINGS AND PRECAUTIONS

Bone Fracture
  • Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines.

ADVERSE REACTIONS

Postmarketing Reports
  • Musculoskeletal: bone fracture