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US FDA says fracture warnings not necessary for OTC PPIs

This article was originally published in Scrip

Executive Summary

The US FDA has determined that over-the-counter (OTC) proton-pump inhibitors (PPIs) used for treating heartburn, such as AstraZeneca's Prilosec (omeprazole), Santarus' Zegerid (omeprazole/sodium bicarbonate) and Takeda's Prevacid (lansoprazole), for short periods at low doses do not increase the risk of fractures, reversing an earlier decision to change the drugs’ labeling.



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