Product labeling changed due to higher fracture risk associated with high doses or long-term use
WEDNESDAY, May 26 (HealthDay News) -- The U.S. Food and Drug Administration has alerted consumers and health care providers regarding the potential increased risk of hip, wrist and spine fractures associated with high doses or long-term use of proton-pump inhibitors (PPIs).
PPIs are available by prescription as esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex), as well as over-the-counter (OTC) as omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).
The labeling for both prescription and OTC PPIs will be updated to address this increased risk. The FDA's decision to revise the labeling of these drugs was based on epidemiologic studies showing an increased risk of fracture of the hip, wrist and spine in patients using PPIs for one year or longer or taking high doses of these drugs. The FDA encourages health care providers and consumers to report adverse events associated with these drugs to FDA's MedWatch Adverse Event Reporting Program or calling 1-800-332-1088.
"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 PPIs, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition," Joyce Korvick, M.D., deputy director for safety in the FDA's Division of Gastroenterology Products, said in a statement.