According to the Food and Drug Administration, there are more than two million patients using Reglan or its generic counterpart, metoclopramide. Reglan is prescribed for treatment of certain digestive disorders, nausea and vomiting. It has also become a popular remedy for the treatment of morning sickness in pregnant women.
Metoclopramide has been on the U.S. market since 1979, and since the early 1980s, studies have suggested a strong link between the long-term use of metoclopramide and Tardive Dyskinesia. Long-term use is characterized as consistent use longer than three months. Tardive Dyskinesia is an involuntary muscle movement disorder that can affect the muscles in the face, arms, legs and body. Symptoms include facial grimacing, tongue twitching and protrusion, lip smacking or puckering, rapid eye blinking, jerking movements in the legs, arms, or torso, and involuntary movement of the fingers. It is estimated that 3 to 5% of long-term users will develop Tardive Dyskinesia each year.
After a recent study suggested that patients were taking Reglan much longer than the recommended three months, the FDA required the makers of Reglan to issue a black box warning emphasizing the risks of developing Tardive Dyskinesia when using Reglan. A black box warning is the strongest warning the FDA can require. The FDA also directed these manufacturers to implement a risk evaluation and mitigation strategy to ensure that patients are provided with the medication safety guide when Reglan or metoclopramide is prescribed.
The number of people suffering from metoclopramide-induced Tardive Dyskinesia is on the rise, and current trends suggest that these numbers will only get higher. According to the FDA’s Adverse Event Reporting System, the number of reported cases rose by more than 6% in the fourth quarter of 2008 and by more than 14% over the second half of 2008. This rise in reporting is significant because this type of increase usually comes after the FDA publicly issues a warning. Here, the FDA did not announce its black box warning until February 2009; therefore, the increased reporting was not attributable to the FDA’s recent warning.
While there are other involuntary muscle movement disorders, Tardive Dyskinesia is potentially irreversible, even if the drug dosage is reduced or discontinued altogether. In some instances, complete withdrawal from the drug can make symptoms worse. This disorder can be extremely debilitating and can have an enormous impact on a patient’s quality of life.
For more information about Reglan and Tardive Dyskinesia, please contact Chad Cook at Chad.Cook@BeasleyAllen.com, or Danielle Mason at Danielle.Mason@BeasleyAllen.com.
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