FDA Requires Proton Pump Inhibitor Label Change

As of September 2010, Proton Pump Inhibitors (PPIs) are required to carry a warning to alert patients of a potential risk of osteoporosis-related bone fractures. According to the U.S. Food and Drug Administration (FDA), the label changes reflect data from several studies that show a possible link between PPIs and an increased risk of fractures of the wrist, thigh and hip.

According to study results, patients who use PPIs for long periods of time and at high doses are at a higher risk of injury. Proton Pump Inhibitors are used to treat acid-related conditions such as gastroesophageal reflux disease (GERD) and ulcers by reducing acid production in the stomach.

The following PPIs are involved: 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 and Zegerid with Magnesium Hydroxide(omeprazole/sodium bicarbonate/magnesium hydroxide) chewable tablets and tablets.

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