The warning spoke mainly to Reglan use in adults and did not mention the risk of side effects in infants. However, the medication is often used off-label as a motility agent in newborns, especially those born preterm. The idea is to get the infant's stomach contents moving to prevent painful acid reflux. Reglan use in infants and children is considered off-label because has not been approved by the FDA.
The issue is that it has not been proved that Reglan is safe or effective when used with newborns and preterm babies. Consider that Reglan was approved for use in 1979 to treat gastrointestinal disorders in adults and it was only in 2009 that the FDA issued the black box warning—the strongest warning possible—about the risk of developing tardive dyskinesia.
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Reglan is only meant to be used for three months or less. The elderly, especially women, are most at risk of developing tardive dyskinesia, and the risk increases with prolonged exposure to the medication. What the risk is for infants and children is not known.
Many people say they or their children were prescribed Reglan for years at a time because they or their doctors did not realize they should not take it for more than three months.
A lawsuit filed against Wyeth, maker of Reglan, alleges that doctors and patients were not adequately warned about the risk of Reglan side effects, including tardive dyskinesia.Risk of Reglan Side Effects in Infants and the Elderly