Personal Injury Law

Reglan Linked to Tardive Dyskinesia - FDA Issues Black Box Warning

By LaBovick Law

Reglan (metoclopramide), a prescription medication used to treat gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD) in children and adults has been linked with Tardive Dyskinesia, a potentially permanent movement disorder.

The FDA approved Reglan for short term use in 1995.  However, approximately, one-third of patients taking Reglan including the generic form, metoclopramide, are on the drug for 12 months or longer. In 27 to 29 percent of the patients, there is a prevalence of Tardive Dyskinesia. 

Tardive Dyskinesia is a neurological disorder that consists of potentially irreversible, involuntary movements of the face, lips, mouth, tongue, and sometimes the legs, arms, 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.

Tardive Dyskinesia is characterized by repetitive, involuntary movements. These symptoms range from being 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. 
 

If you or a loved one has developed Tardive Dyskinesia as a result of taking Reglan, see your doctor immediately for an evaluation.

FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide/ Reglan

Full post as published by LaBovick Injury Law Blog on May 20, 2010 (boomark / email).