A Medline abstract for a paper in the January 2005, Movement Disorders Journal, reported the "first documented case of tardive dyskinesia in an infant," developed at 2 months "after a 17-day treatment with metoclopramide for gastroesophageal reflux."
The "Pediatric Gastroesophageal Reflux Clinical Practice Guidelines," in the October 2009, Journal of Pediatric Gastroenterology and Nutrition, warn that "Metoclopramide commonly produces adverse side effects in infants and children, particularly lethargy, irritability, gynecomastia, galacctorhea, and extrapyramidal reactions and has caused permanent tardive dyskinesia."
An infant treated for GERD, born to a mother who took Reglan for morning sickness and to increase breast milk, would undergo triple exposure.
Women Need Warnings
"Women need to be aware of the potential risk Reglan poses to themselves and their children," according to Roger Drake, the lead Reglan attorney at the California-based Baum, Hedlund, Aristei & Goldman law firm, in cases of persons who developed TD.
Concerns about tardive dyskinesia extend to children and infants, especially babies born prematurely, who may have been treated with Reglan to stimulate their digestive system, Drake reports.
He points out that no studies have been conducted to examine the risk of tardive dyskinesia in babies whose mothers take Reglan, even though the drug makers know that Reglan is used in such circumstances.
The adverse effects for babies are the same as for adults, he says, but infants are more at risk because there are no FDA approved dosing requirements established for the safe use of Reglan with children of any age, much less infants.
Baum Hedlund has two decades of experience representing thousands of injured clients against drug companies.
(This article is part of the Reglan Litigation Update Series and is sponsored by the Baum, Hedlund, Aristei & Goldman law firm)
(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)