Tardive Dyskinesia is a neurological disorder that consists of potentially irreversible, involuntary movements of the tongue, mouth, face, lips, and sometimes the arms, legs, and trunk. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase with the duration of Reglan use and the total cumulative dose. On February 26, 2009, the U.S. Food and Drug Administration (FDA) announced that manufacturers of metoclopramide must add a black box warning to their drug labels to warn about the risks associated with its long-term or high-dose use.
The FDA approved Reglan in 1995 for short-term use, generally 4 to 12 weeks. However, one-third of patients taking Reglan and the generic form, metoclopramide, are doing so for periods of 12 months or longer. Of these long-term users, there is a prevalence of Tardive Dyskinesia in 27 to 29 percent of these patients.
Tardive Dyskinesia is characterized by repetitive, involuntary movements. These symptoms range from very mild to very severe, which may be irreversible. Some of these symptoms include:
Jerking movements of the tongue, face, mouth, and jaw
Involuntary movement of the hands and fingers
Uncontrolled movement of the arms, legs, and trunk
