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Most babies spit up during their first few months of life. For many of those babies (and their parents) it is a messy but benign condition. However, for some infants it is a sign of a more serious condition known as gastroesophageal reflux disease or GERD. GERD is a painful condition that causes vomiting and poor weight gain. It occurs when stomach contents come back into the esophagus. If an infant with GERD is chronically uncomfortable or failing to gain weight at a safe rate then a doctor may prescribe medication.
The Off Label Use of Reglan for Infants Can be Dangerous
One of the medications used to treat infant GERD is Reglan. However, parents should be aware that the FDA has not approved Reglan for use in infants or children and an infant's prescription for Reglan is considered an off label use. While, doctors are not prevented from prescribing a drug for an off label use, pediatric doctors and parents should be concerned about Reglan prescriptions for infants.
Since at least 2006, the American Academy of Pediatrics has been concerned about the use of Reglan to treat infant reflux because of its "widespread use and growing concern about toxicity." While the 2006 review of Reglan was inconclusive, it did suggest that a larger study be done to determine both the efficacy and toxicity of Reglan on infants.
Nevertheless, many doctors have continued to prescribe Reglan to infants. In 2009, the FDA issued a black box warning informing physicians and patients that Reglan use has been linked to tardive dyskinesia. Parents of infants taking Reglan should speak with the prescribing physician as soon as possible.
If your child has suffered the devastating and most often irreversible effects of tardive dyskinesia from off label Reglan use then please contact a Relgan attorney to discuss your legal options.