FDA weighs in on reflux meds with strong warning

The U.S. Food and Drug Administration said that 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.Package insert labels for the drugs will be changed to describe the possible increased fracture risks, the FDA said."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," Korvick said.Moreover, the FDA said doctors and patients should weigh whether known benefits of the drugs outweigh potential risks.Other proton pump inhibitors used to treat heartburn, known formally as gastroesophageal reflux disease (GERD), include generically available Protonix, Johnson & Johnson's prescription Aciphex brand and Novartis AG's over-the-counter Prevacid.