Nexium®, Protonix Linked to Bone Fractures, FDA Says

SOURCE
Bloomberg Businessweek
By Molly Peterson
May 25, 2010
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AstraZeneca Plc’s Nexium, Pfizer Inc.’s Protonix and Takeda Pharmaceutical Co.’s Prevacid may raise the risk of bone fractures when taken in high doses or for a year or more, U.S. regulators said.

The medicines are approved to treat ulcers, acid reflux disease and inflammation of the esophagus, the agency said today in a statement. The warning is based on a Food and Drug Administration review of several studies of the treatments known as proton pump inhibitors, the statement said.

The studies found an increase of hip, wrist and spine fractures in patients, particularly those older than 50 years old, the FDA said. The drugs, which are also used off-label for heartburn and indigestion, had U.S. sales of $13.9 billion annually, according to an editorial that accompanied two studies published May 10 in the Archives of Internal Medicine.

“Health-care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition,” said Joyce Korvick, deputy director for safety in the FDA’s Gastroenterology Products division, in a statement today.

Takeda’s Dexilant, Johnson & Johnson’s Aciphex, and prescription and over-the-counter versions of Prevacid and AstraZeneca’s Prilosec also were cited in the FDA’s drug-safety posting.