New Generic Version of Reglan to Carry Black Box Warning

Earlier this month, Salix Pharmaceuticals, Ltd. received approval to begin marketing its new Metoclopramide drug to treat diabetic gastroparesis and gastroesophageal reflux disease (GERD). However, unlike the brand name version of the drug, Reglan and its earlier generic counterparts, this new metoclopramide drug will be required to carry the strongest FDA warning, a black box warning which advises physicians about the drug’s dangers and association with the permanent movement disorder tardive dyskinesia. The new drug will also advise physicians and healthcare professionals that the drug should not be taken for a period longer than 12 weeks to avoid any onset of the neurological disorder tardive dyskinesia.
Earlier versions of the drug did not carry such a warning and patients that have contracted the permanent disorder have filed Reglan lawsuits against the manufacturers of both Reglan and the various generic equivalents known as metoclopramide.