- FDA recommends lower dose, shorter duration of use
- Drugs include Nexium, Prilosec, Prevacid, Protonix
- Package insert labels to include fracture-risk warnings
U.S. health regulators have cautioned doctors and patients of an increased risk of fractures of the hip, wrist, and spine from high doses or long-term use of a widely used class of drugs to control the amount of acid in the stomach.
The class of heartburn drugs, called proton pump inhibitors, include prescription brands such as AstraZeneca Plc’s top-selling Nexium and the company’s Prilosec, an older generic treatment that is also available over the counter at a lower dosage strength.
The U.S. Food and Drug Administration said on Tuesday 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.
The FDA recommended that consumers report any side effects or other product problems to its MedWatch Adverse Event Reporting program at http://www.fda.gov/MedWatch or by calling 800-332-1088. (Reporting by Ransdell Pierson, Bill Berkrot and Lewis Krauskopf; Editing by Tim Dobbyn).