Bone fracture risk increases with some antacid drugs, says FDA

Washington - There is a possible increased risk of bone fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers, warns the Food and Drug Administration. The FDA is seeking stronger warning labels for these medications.

The drugs belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach. They are available as prescription and over-the-counter. The prescription PPIs treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus. The PPIs available over-the-counter are used to treat frequent heartburn, reports the Food and Drug Administration (FDA). The prescription PPIs are Nexium, Dexilant, Prilosec, Zegerid, prevacid, Protonix, Aciphex, Vimovo according to the FDA. Over-the-counter versions of PPIs include Prilosec OTC, Zegrid OTC and Prevacid 24HR. FDA has reviewed seven published studies, six of which reported an increased risk of fractures of the hip, wrist, and spine with the use of PPIs. Based on the available data, it is not clear at this time if the use of PPIs is the cause of the increased risk of fractures seen in some studies. FDA is working with the manufacturers of PPIs to further study this possible risk. Most of the studies evaluated individuals 50 years of age or older, and the increased risk of fracture was seen mainly in this age group. As a precaution, FDA is revising the labels for both the prescription and the over-the-counter PPIs to include new safety information about the possible increased risk of fractures of the hip, wrist, and spine with the use of these medications The FDA reports advise consumers to not stop taking PPI medications unless without first speaking to your health care provider. PPIs are effective in treating a variety of gastrointestinal disorders. The FDA says that although an increae is fractures of the hip, wrist and spine have been reported in these studies the greatest risk was seen in those who take high doses for an extended period of time. The FDA warning conclude by saying to read and follow the directions on the “Drug Facts” label when considering the use of an over-the-counter PPI. Be aware that the over-the-counter PPIs should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your health care professional. No more than three 14-day treatment courses should be used in one year. Talk to your health care professional about any concerns you may have about using PPIs. The FDA asks if you have experienced any side effects from the use of PPIs to report them to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone at (800) 332-1088.