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FDA: Possible Fracture Risk With High Dose, Long-term Use of Proton Pump Inhibitors
Date:5/25/2010

and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition."

FDA's warning and decision to revise the labeling of proton pump inhibitors are based on the Agency's review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist and spine in patients using proton pump inhibitors. Both the Warnings and Precautions section of the prescription labeling and the Drug Facts label on OTC proton pump inhibitors will address these findings.

Health care professionals and consumers should weigh the known benefits against the potential risks of proton pump inhibitors when determining if these medications are appropriate for treatment. Consumers also should talk with their health care professional about any concerns.

Any side effects or other product problems with proton pump inhibitors should be reported to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

For more information

Drug Safety Communication

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm

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SOURCE U.S. Food and Drug Administration
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