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FDA Warns of Fracture Risk With Popular Heartburn Drugs
Date:5/25/2010

Label change to Nexium, Prilosec and other medications should spur patient-doctor discussions, agency says,,

TUESDAY, May 25 (HealthDay News) -- Blockbuster heartburn medications such as Prevacid, Prilosec and Nexium will now carry a warning on their labels linking the drugs to a heightened risk for fractures, the U.S. Food and Drug Administration announced late Tuesday.

The label will advise consumers to use this class of medicines, called proton pump inhibitors (PPIs), carefully, because high doses have been associated with an increased risk of fractures of the hip, wrist and spine, the agency said.

PPIs, which include prescription and over-the-counter drugs, work by blocking stomach acid from being produced. However, as with any drug, this benefit comes with some risk, the FDA said.

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

"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," she said.

Based on a review of the scientific evidence, the agency is instructing the makers of the drugs to change the labels for both the prescription and the over-the-counter versions of the proton pump inhibitors. The FDA based its decision on the results of seven studies, six of which noted a link between PPIs and fracture, primarily among users aged 50 and over.

Proton pump inhibitors include the drugs Nexium (esomeprazole), dexlansoprazole (Dexilant), Prilosec/Zegerid (omeprazole), Prevacid (lansoprazo
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