The U.S. Food and Drug Administration (FDA) has issued its most severe “black box” warning for the drug Reglan®. The warning states that there is a link between Reglan® and tardive dyskinesia when Reglan® is used long-term, more than 90 days, and/or at high doses. This high level of warning means the FDA will require the manufacturer of Reglan® to provide patients and doctors with a risk assessment and a plan to mitigate the dangers of the drug and ensure that it is being used safely. It is unknown how Reglan® causes tardive dyskinesia.
The drug Reglan® is primarily used to treat gastrointestinal problems such as gastroesophageal reflux disease (GERD) and gastroparesis. GERD results when a small amount of digested food moves in reverse from the stomach into the esophagus. This backflow of food creates a burning sensation or a feeling of pressure in the upper chest. In gastroparesis the emptying of the stomach is sluggish, probably as a result of faulty nerve signals, causing nausea and bloating.
Reglan® improves GERD and gastroparesis by enhancing the contraction of the stomach muscles, allowing the stomach to empty properly before backflow can occur. GERD and gastroparesis are typically long-term afflictions requiring treatment for greater than 90 days at a time. The long-term treatment of these gastrointestinal problems increases the dangers of Reglan® and tardive dyskinesia onset.
Tardive dyskinesia is a movement disorder characterized by uncontrollable, haphazard movement most noticeable in the face and limbs. The facial movements can involve repetitive protruding tongue motion, lip puckering, eyebrow raising, and chewing. In the limbs, the involuntary motions may involve stomping, rocking, and finger wiggling. These movements are uncontrollable, so the embarrassing constant motion can impair daily life and impact social interactions. The most alarming concern over the link between Reglan® and tardive dyskinesia is that the symptoms of tardive dyskinesia typically do not subside after Reglan® use has been stopped.
The FDA warning about the dangers of Reglan® and tardive dyskinesia suggest that doctors and their patients need to carefully consider any use of this drug. Doctors should resort to this drug only when other drugs have been tried and failed. In addition, the use of Reglan® should be restricted to less than 90 days, the dose should be keep as low as possible to treat the problem, and the patient should be monitored for any symptoms of tardive dyskinesia. Finally, the dangers and guidelines should be thoroughly reviewed with the patient before Reglan® is taken.
