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Reglan for infants is a somewhat controversial treatment. The safety of Reglan for infants is under question as the U.S. Food and Drug Administration has not approved Reglan for any use in children, let alone in infants. The dangers of Reglan side effects for infants are essentially the same as those for adult patients, but infants are particularly at risk because there is no approved dosage of Reglan for infants — Reglan dosages are configured only for adults.
Thus, Reglan treatment for infants, in any context, is definitely an "off-label" usage of this drug. Although it is not illegal for a physician to prescribe Reglan or another drug for an off-label use — in this case, for an infant — it is not recommended by the FDA.
Reglan, or metoclopramide, is an anti-emetic agent; that is, it helps a person keep from vomiting. When an infant has a greater-than-normal rate of vomiting (in an infant, "spitting up" may be considered a form of vomiting), some physicians may prescribe Reglan. An infant who is vomiting or spitting up 20 or more times a day may fall into this category.
Reglan has also been prescribed for infants diagnosed with GERD (gastroesophageal reflux disease) or acid reflux. These similar conditions occur when the contents of the stomach come back up into the esophagus after or during a meal. Of course, it's perfectly normal for babies to spit regurgitated food back up — over half of all infants have reflux incidents in the first three months of life. Most babies' reflux stops by the time they're 12 to 18 months old.
In a small number of infants, the symptoms of spitting up, vomiting and coughing (i.e., GERD symptoms) are bad enough that they cause:
However, the Reglan drug is not an FDA-approved treatment for infant GERD.
If your infant has been harmed by Reglan treatment, contact us today to speak with an experienced Reglan lawyer that represents individuals who suffered an illness or injury due to the unapproved use of a drug. We will schedule a private, complimentary consultation to discuss your case and determine whether you are eligible to recover compensation for your losses.
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