Last year, the Food & Drug Administration issued a black box warning, the strongest of its kind, for the drug Reglan and its generic forms metoclopramide, stating that the medication had "been linked to tardive dyskinesia." In fact, Reglan and metoclopramide use has been identified as the leading cause of tardive dyskinesia (TD) among patients with the disorder in the United States.
The FDA approved Reglan for short-term use - no longer than three months - in 1979 as a treatment for various gastrointestinal disorders, namely gastroparesis and gastroesophageal reflux disease (GERD). But, prior to the FDA's action last year, the very serious risks posed by the drug were not made clear to the public on its labeling. As a result, several lawsuits have been filed across the country against the drug's manufacturers.
Evidence of the risks posed by Reglan and metoclopramide had been around for years. In 1983 the Annals of Internal Medicine ran a letter warning of metoclopramide's possible neurological side effects, including TD. A Neurology study published in 1984, found that the incidence rate of TD was two to three times higher for long-term metoclopramide patients 70 and older. And by 1992, the Archives of Family Medicine was expressing serious concerns about the dangers of long-term metoclopramide use, particularly in the elderly and diabetic.
Despite these studies displaying that Reglan and metoclopramide posed a clear risk to patients, the drug's manufacturers did nothing to alert the public of the danger. Even more troubling is the fact that there was significant evidence released over the last 30 years that showed the drug had little to no value as a treatment for GERD.
A study published in Gastroenterology in 1975, four years before Reglan was approved by the FDA, acknowledged that while the drug might provide some relief for GERD patients, it had little to no effect on serum gastrin levels. The American Journal of Gastroenterology published another study in 1983 concluding that while metoclopramide provided temporary relief of GERD symptoms, it had no significant effect on symptoms of esophagitis. And finally, a 2006 study published in Nature Clinical Practice: Gastroenterology & Hepatology concluded that "the evidence base for the use of [metoclopramide for GERD] is weak, with little or no sustained effect on acid exposure or healing of esophagitis."
These medical studies, along with the fact that metoclopramide is only approved for short-term use, while GERD is generally a chronic condition, suggest that there is very little value in metoclopramide for treating patients suffering from GERD. And with the significant health risks posed by the drugs, it seems only logical that the FDA should withdraw its approval of the medication for treatment of the condition. The companies that continued to market the drug despite the evidence listed above must be held accountable for the injuries caused in the thousands of patients taking their product over the last three decades.