In February 2009, the Food and Drug Administration ordered the manufacturers of Reglan and its generic equivalent, metoclopramide, to add a “black-box” warning alerting patients of an increased risk of a type of involuntary movement disorder known as tardive dyskinesia.
Reglan and metoclopramide are designed to treat gastrointestinal disorders, including gastroesophageal reflux disease and diabetic gastroparesis. The drugs work by increasing the movement of the stomach muscles, which speeds up the rate at which the stomach empties into the intestines.
However, the FDA says that Reglan and metoclopramide may also cause tardive dyskinesia, a condition which can cause repeated, involuntary movements of the extremities. Other symptoms of tardive dyskinesia include involuntary grimacing, lip movements, blinking, rapid eye movement, sticking out the tongue and problems moving the fingers.
These side effects of Reglan and metoclopramide are especially serious because tardive dyskinesia has no known treatment and the symptoms of the disease are rarely reversible. The FDA says that in some cases of tardive dyskinesia, these symptoms may become less severe after a patient stops taking Reglan or metoclopramide.
Several recent studies have found that Reglan and metoclopramide are the most frequent causes of drug-induced movement disorders. One study showed that about 20% of patients who took one of the two drugs for more than three months developed tardive dyskinesia.
Because of the risk of Reglan side effects, the FDA has advised physicians that the drugs should only be used in cases where the benefits of treatment outweigh the risks. Patients who have been taking one of the drugs for an extended period of time and elderly patients, especially women, are at the greatest risk of developing tardive dyskinesia.
If you or a loved one have developed symptoms of tardive dyskinesia after taking Reglan or metoclopramide to treat a stomach disorder, contact the law office of Hissey Kientz, LLP to discuss your legal rights. You can contact us by calling our toll-free number at (866) 275-4454, or by filling out a free case evaluation form to the right of this page.