A cursory search of the web for articles or news stories this past week has uncovered some strange stories about the FDA’s issuance of a black box warning for the drug. It’s odd because that occurred over a year ago. This isn’t new news. Reglan was issued a black box warning for its association with tardive dyskinesia, a serious and permanent neurological disorder. Reglan is to be used for no more than three months. Longer use of the drug increases the risk of acquiring tardive dyskinesia.
Besides the odd stories about the black box warning, there are other stories about Reglan use in the infant population. Babies may have underdeveloped gastrointestinal tracts and may experience symptoms similar to gastroesophageal reflux disease. Babies experiencing such symptoms are often treated with Reglan even though the drug is not approved for infant use and studies have not determined if babies are being subjected to the risk of developing tardive dyskinesia. It’s not known how Reglan may affect infants. What we do know is that the neurological disorder linked to prolonged use of Reglan in adults is serious and permanent. If the risk is similar for infants, Reglan is simply to dangerous to use with infants.