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A class of drugs used to control stomach acid has been linked to an increased risk of hip, wrist, and spine fractures.
The US Food and Drug Administration said a review of patients using high doses of proton pump inhibitors over a long period of time had raised the possibility of a connection.
The class of treatments includes AstraZeneca’s Nexium and Prilosec, Johnson & Johnson’s Aciphex and Novartis’s Prevacid.
“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,” Joyce Korvick, deputy director for safety in the FDA’s Division of Gastroenterology Products, said in an agency statement.
“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.”
Package insert labels for the products will be changed to describe the possible increased fracture risks, the FDA added.
Copyright Press Association 2010
Food and Drug Administration
