The FDA has warned that taking certain drugs to treat symptoms of heartburn, acid reflux or ulcers may increase the risk of hip, wrist and spine fractures. The drugs belong to a class of medications called proton pump inhibitors, (PPIs), which work by reducing the amount of acid in the stomach. The drugs are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus. They are also available over-the-counter to treat frequent heartburn. The prescription PPIs are Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex and Vimovo. The over-the-counter PPIs are Prilosec OTC (omeprazole), Zegerid OTC (omeprazole) and Prevacid 24HR (lansoprazole).
The FDA has found, based on a review of several epidemiological studies, that consumers who received high doses of PPIs or used them for one year or more were at greater risk for wrist, hip and spine fractures. The majority of studies evaluated individuals 50 years of age or older. The increased risk of fracture primarily was observed in this age group.
While it’s not clear whether the use of PPIs is the cause of the increased risk in fractures, the FDA is working with the manufacturers of PPIs to further study this possible risk. In the meantime, as a precaution, the “Drug Facts” label on both the prescription PPIs and the OTC varieties, which are indicated for 14 days of continuous use, are being revised to include information about this risk. “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,” according to Dr. Joyce Korvick, deputy director for safety in the FDA’s Division of Gastroenterology Products.
For patients with pre-existing osteoporosis, the FDA suggested no action other than management of bone status according to current standards for clinical practice along with adequate vitamin D and calcium supplementation. In November the FDA issued a warning about concomitant use of the PPI omeprazole (Prilosec and Prilosec OTC) and clopidogrel. The PPI was found to blunt the antiplatelet effect of clopidogrel. Consumers are advised by the FDA not to stop taking PPIs unless told to do so by their health care professional. The FDA also says consumers should also be aware that OTC PPIs should only be used as directed for 14 days for the treatment of frequent heartburn. They say that no more than three 14-day treatment courses should be used in one year. Any questions or concerns about PPIs should be directed to a health care professional. If you need more on this subject, contact Ted Meadows at 800-898-2034 or by email at Ted.Meadows@beasleyallen.com.
Source: FDA Release
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