Safety

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

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.