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FDA Warns on Fracture Risks With PPIs


 

The Food and Drug Administration issued a warning to physicians and consumers that proton pump inhibitors may increase the risk of hip, wrist, and spine fractures.

The agency said that it is changing the labeling for prescription and over-the-counter versions of proton pump inhibitors (PPIs) to reflect new safety information that is the result of a review of seven epidemiologic studies. Most of the observed risk was in people older than age 50 years and those who took high doses or used the drugs for more than a year. Prescription PPIs include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). There are OTC versions of Prilosec, Zegerid, and Prevacid.

“Because these products are used by a great number of people, it's important for the public to be aware of this possible increased risk 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,” said Dr. Joyce Korvick, deputy director for safety in FDA's Division of Gastroenterology Products, in a statement.

The FDA did not have access to the raw data in the studies; it merely reviewed what was published. But, said the FDA, it accepted the results because the studies appear to be well designed. Even so, those studies had limitations, and there is still no understanding of why PPIs might lead to fractures.

The full agency communication is located at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm

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