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FDA NEWS RELEASE: PPI Warning

For Immediate Release: May 25, 2010
Media Inquiries:
Elaine Gansz Bobo, 301-796-FDA: Possible Fracture Risk with High Dose, Long-term Use of Proton Pump Inhibitors
The U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased
risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump
inhibitors.
The product labeling will be changed to describe this possible increased risk.
Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount of acid in the stomach. Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and (Aciphex) rabeprazole. Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. OTC versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR). “Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one
year or longer, or at high doses,” said Joyce Korvick, M.D., deputy director for safety in FDA’s Division of
Gastroenterology Products. “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.”

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 The following instructions are taken directly from 14-Day Course of Treatment: Swallow 1 tablet with a glass of water before eating in the morning; take every day for 14
days; do not take more than 1 tablet a day; do not chew or crush the tablets; do not crush tablets in food ; do not use for
more than 14 days unless directed by your doctor

Repeat 14-Day Courses (if needed): You may repeat a 14-day course every 4 months; do not take for more than 14
days or more often than every 4 months unless directed by a doctor

Source: http://mrg-llc.com/drglab/Documents/FDA%20NEWS%20RELEASE%20PPI%20Warning.pdf

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