Warning on Proton Pump Inhibitors and Fracture Risk

FDA is cautioning healthcare professionals and patients that proton pump inhibitors (PPIs) may increase the risk of fractures of the hip, wrist and spine. The drugs' labeling will be revised to reflect these concerns. PPIs are used to reduce gastric acidity, and include Nexium (esomeprazole), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Protonix (pantoprazole), Aciphex (rabeprazole) and Prevacid (lansoprazole).

The new safety information is based on FDA's review of several epidemiological studies. These studies found that patients who received high doses of the drugs or took them for a year or more had the greatest fracture risk. Since most of these patients were older than 50, the increased risk was observed mainly in this age group.

Healthcare professionals prescribing proton pump inhibitors should consider the possibility of an increased fracture risk, and whether a lower dose or shorter duration of therapy might be possible. Patients at risk for osteoporosis should have their bone status managed, and should supplement their diets with adequate amounts of vitamin D and calcium.

Patients taking prescription PPIs should understand the possibility of an increased fracture risk, but they should be told not to stop their medication without consulting their healthcare professional. People using over-the-counter PPIs to treat heartburn should be cautioned not to take these drugs for more than 14 consecutive days, and not to take more than three 14-day treatment courses in one year.

FDA Patient Safety News: August 2010

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=101#1

Category:

Education

Tags:

• GERD
• fracture
• Nexium
• Prilosec
• Zegerid
• Prevacid
• PPI drug
• side effect
• FDA