FDA Warns Acid Reflux Drugs May Increase Fracture Risk
The medications you take to treat symptoms of heartburn or acid reflux (gastroesophageal reflux disease, GERD) may be having an effect on more than your digestive system—they could also harm your bones. The Food and Drug Administration (FDA) is warning consumers and health care professionals that long-term or high-dose use of proton pump inhibitors may increase the risk of fractures.
Proton pump inhibitors, both over-the-counter (OTC) and prescription, are among the most commonly used drugs in the United States. According to Consumers Report, these medications are the third highest-selling group of drugs in the United States, and one specifically—Nexium—had the second highest retail sales among all drugs in 2008 at $2.8 billion. Overall, 113.4 million prescriptions for proton pump inhibitors are written each year.
Proton pump inhibitors are often prescribed to treat chronic conditions, so many patients end up taking these drugs for many years. Numerous studies have indicated that long-term use of this group of medications is associated with an increased risk of fracture. Proton pump inhibitors inhibit the production and intragastric secretion of hydrochloric acid, which plays an important role in mediating the absorption of calcium in the small intestine. Therefore long-term use of these drugs has the potential to be detrimental to bone health.
The FDA warning will result in new product labeling that will describe the possible increased risk of fracture associated with use of the medications. Prescription proton pump inhibitors include dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (Aciphex). Both lansoprazole and omeprazole are also available OTC.
According to Joyce Korvick, MD, deputy director for safety in FDA’s Division of Gastroenterology Products, “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.” A recent study published in the Archives of Internal Medicine evaluated the risk of fracture among 130,487 postmenopausal women ages 50 to 79 who were enrolled in the Women’s Health Initiative study. The researchers found an increased risk of spinal, forearm, wrist, and total fractures associated with the use of acid reflux medications, but no relationship with hip fractures.
A Canadian study, however, did find an increased risk of hip fracture in both men and women who had taken proton pump inhibitors for five years or longer. The study evaluated 15,792 cases of osteoporosis-related fractures and 42,289 controls and observed a significant risk of hip fracture after five years of medication use and a significant increased risk of all fractures among those taking the drugs for seven years or longer.
The FDA notes that consumers and health care professionals should weigh the benefits and potential risks when considering use of heartburn and acid reflux medications. Both the Warnings and Precautions section of the prescription labeling and the Drug Facts label found on OTC proton pump inhibitors will reflect the new warning.
FDA consumer update, May 25, 2010
Gray SL et al. Archives of Internal Medicine 2010; 170(9): 765-71
Targownik LE et al. Canadian Medical Association Journal 2008 Aug 12; 179(4)