FDA Says Popular Acid Reflux Drugs Pose Risks of Fractures and Infection

By June 4, 2010Dangerous Drugs

As a defective medication lawyer, I noticed a recent spate of reports about alarming risks posed by the third highest-selling class of drugs in the U.S. Six studies have linked the most powerful class of acid reflux drugs, known as proton pump inhibitor antacids, or PPIs, to bone fractures, especially for people who take high doses for a year or more and for people over age 50, because the drugs may disrupt the body’s ability to absorb calcium. Another study suggests an increased risk of infection with C. difficile bacteria for patients using this class of drugs.
The FDA advises consumers of “possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers.” The warning extends to well-known drugs such as dexlansoprazole (Dexilant), esomeprazole (Nexium), omeprazole (Prilosec and Zegerid), pantoprazole (Prevacid) and rabeprazole (Aciphex), all of which will be required to carry this information on a warning label on both prescription and non-prescription packaging. Patients whose doctors advised them to take PPIs should ask whether they should continue taking them, says the FDA. Patients are advised to use the drugs for only 14 days at a time, and for no more than three 14-day periods over the course of a year. The FDA also suggests that patients and doctors consider lower doses and shorter durations of therapy with PPIs.
PPIs work by stopping stomach acid from being produced, and they are only supposed to be taken for serious conditions like gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the esophagus. But often, people use them for less serious issues like heartburn, which could be treated with less risk of side effects by using antacids like Maalox, Rolaids, or Tums, or hydrogen receptor antagonist drugs like Axid, Pepcid, Tagamet, and Zantac. In fact, doctors write 113.4 million prescriptions for PPIs annually, and three PPIs — Prevacid, Prilosec, and Zegerid — are available over the counter.
As a pharmaceutical liability attorney, I wonder why doctors and consumers were in the dark about the risks of using PPIs before the FDA issued its warning. The FDA isn’t the only party responsible for warning and protecting the public from risky drugs; the drug manufacturers have a legal responsibility to do this too. Surely the drug manufacturers had access to the six epidemiological studies on which the FDA based its warning. They should have let consumers know of these risks as soon as they knew, as they are legally required to do. Drug manufacturers who fail to warn consumers of risks that they know to be linked to their products violate their legal responsibility, and the law allows consumers harmed by the defective drugs to recover compensation for that harm. That means that a consumer who incurs medical costs, misses work or whose quality of life suffers because of negative effects of a dangerous drug can require the drug manufacturer to pay these costs, which the manufacturer ultimately caused.


The dangerous medication attorneys at Carey, Danis & Lowe help people who have been hurt by over-the-counter and prescription drugs. If you or someone you has have been seriously harmed by a medication, we can advise you about making the company that caused your injury pay for all of your financial costs and compensation for your injuries. To learn more about pursing a defective drug claim, please call Carey, Danis & Lowe for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.