Label Changes for:
Zegerid with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) chewable tablets and tablets
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
- 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
WARNINGS AND PRECAUTIONS
- 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.
- Musculoskeletal: bone fracture