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FDA Date: 3/23/11
FDA Drug Safety Communication Update for PPIs
Possible Increased Risk of Fractures of the Hip, Wrist, and Spine with the Use of Proton Pump Inhibitors
FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication "Drug Facts" label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low-dose PPI use is unlikely.
The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.
In contrast to prescription PPIs, OTC PPIs are marketed at low doses and are only intended for a 14-day course of treatment up to 3 times per year. FDA acknowledges that consumers, either on their own or based on a healthcare professional's recommendation, may take these products for periods of time that exceed the directions on the OTC label. Healthcare professionals should be aware of the risk for fracture if they are recommending use of OTC PPIs at higher doses or for longer periods of time than in the OTC PPI label.