FDA Warns of Fracture Risk with PPIs

May 26, 2010— -- Proton pump inhibitors (PPIs) may increase the risk of fractures of the hip, wrist, and spine with high-dose or chronic use, the U.S. Food and Drug Administration warned Tuesday.

Labeling on drugs in this class -- both prescription and over-the-counter -- will change to reflect this risk, the agency said. Prescription PPIs include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Acihpex).

The FDA suggested considering whether a lower dose or shorter duration of therapy would be adequate when prescribing proton pump inhibitors.

The warning and decision to revise labeling came after an FDA review of epidemiologic studies reporting elevated fracture risk at the hip, wrist, and spine.

These studies included primarily adults 50 and older and suggested the greatest risk is in this age group and among individuals who used the drugs for at least a year or who had been taking high doses of prescription formulations.

Although over-the-counter PPIs -- Prilosec OTC, Zegerid OTC, and Prevacid 24HR -- are indicated for only 14 days of continuous use, the FDA said these labels were also being revised as a precaution.

"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," said Dr. Joyce Korvick, deputy director for safety in the FDA's Division of Gastroenterology Products, in an FDA press release.

However, the agency cautioned patients that they need to consider the risk-benefit ratio with their physician before deciding to discontinue treatment.

For patients with pre-existing osteoporosis, the FDA suggested no action other than management of bone status according to current standards for clinical practice along with adequate vitamin D and calcium supplementation.

In November the FDA issued a warning about concomitant use of the PPI omeprazole (Prilosec and Prilosec OTC) and clopidogrel. The PPI was found to blunt the antiplatelet effect of clopidogrel.