Long Term Use of Reglan Leads to Rising Number of Lawsuits

Use of the gastrointestinal drug Reglan, and other generic drugs containing Metoclopramide, can cause a disabling neurological syndrome known as Reglan tardive dyskinesia, which involves involuntary and repetitive movements that can be permanent. These Reglan neurological problems are devastating and socially disabling, causing severe physical, mental, social and emotional suffering. In February 2009, the U.S. Food & Drug Administration (FDA) mandated that the makers of Reglan add a black box warning to its label regarding the risk of tardive dyskinesia associated with chronic, long-term use. The FDA’s mandate followed the publication of analyses that suggested that Reglan is the most common cause of drug-induced movement disorders. 

To prevent tardive dyskinesia and other Reglan side effects, the drug should not be taken for more than 12 months, and it has not been approved for longer user. However, it has become

apparent that doctors have been prescribing Reglan for much longer periods. Reglan tardive dyskinesia lawsuits allege that Wyeth Pharmaceuticals knew of a widespread tendency among physicians to mis-prescribe Reglan, and promoted the drug for longer use despite the lack of safety data to support such uses. Previously, it was not recommended that metoclopramide-containing drugs like Reglan be used for more than three years due to the risk of Reglan side effects. Reglan tardive dyskinesia side effects are more likely to occur with long-term use of the drug, use at high doses and among the elderly, especially women.

A number of tardive dyskinesia lawsuits also name the manufacturers of generic forms of Reglan as defendants. Last year, the U.S. Court of Appeals for the Firth Circuit rejected the argument by a generic drug maker that federal law preempts a state-law failure-to-warn claim filed by a user of generic Reglan who developed tardive dyskinesia. Since then, that appeal has been overturned and the supreme court found for the defendants, stating that “We acknowledge the unfortunate hand that federal drug regulation has dealt,” Thomas wrote, but went on to state that it is not the court’s job to decide if regulations passed by Congress are unusual or bizarre. Despite the growing number of Reglan tardive dyskinesia, no move towards consolidation has been made as of yet.