The FDA is reporting 106 cases of adverse effects linked to the popular drug Reglan and its generic version metoclopramide. The drug has been linked to a serious neurological disorder tardive dyskinesia when it is taken for longer than a 90 day period. Metoclopramide was approved for use by the FDA for short term treatment of certain gastrointestinal disorders such as gastroesophageal reflux disease (GERD) in people who fail to respond to other treatments, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines).
According to the FDA more than two million US patients use metoclopramide. One study has determined that 20% of patients who take metoclopramide for a period longer than 90 days develop tardive dyskinesia, a serious neurological disorder. Patients suffering from tardive dyskinesia present the following symptoms: grimacing, chewing, smacking of lips, rapid eye movements and rapid movements of the fingers, arms, legs, and trunk.
Tardive dyskinesia is permanent and there is no known treatment.
These adverse events led the FDA to order a black box warning in February 2009. The warning informs healthcare professionals that prolonged use of Reglan (metoclopramide) should be avoided except in rare cases.