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LAWSUITS NEWS & LEGAL INFORMATION

Should Reglan Be Used to Treat Infants and Children?

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Baton Rouge, LAReglan side effects in adults are well-documented, but not a lot is known about the long-term effects of Reglan on infants. Although some studies have undertaken to determine Reglan's safety in children and infants, the results so far have been inconclusive.

Reglan, also known as metoclopramide, is frequently used off-label to treat gastroesophageal reflux disease (GERD) and erosive esophagitis in infants and children. While this is certainly not illegal, it means that the drug has only been approved for use in adults, and has not been proven to be safe and effective for use in infants and children.

As a result, the proper dosage of Reglan for children has yet to be determined. What is known is that the longer a person is on Reglan, the higher the risk of developing adverse reactions such as tardive dyskinesia. The FDA recommends that patients take Reglan for no more than 12 weeks. However, many adults and children have been taking Reglan for much longer than the recommended three months.

A 2006 study published in Pediatrics, the journal of the American Academy of Pediatrics, attempted to determine the safety and efficacy of metoclopramide use in infants.

"Given its [metoclopramide's] widespread use and growing concern about toxicity in this population, we conducted a systematic review of metoclopramide for the treatment of gastroesophageal reflux disease in infants," researchers wrote.

The researchers analyzed previous studies of metoclopramide use in infants, which yielded a variety of results—in some cases GERD symptoms worsened; in others, symptoms improved; and sometimes metoclopramide had no effect on GERD. There was also a significant placebo effect. Some studies also found that use of metoclopramide in infants was linked to adverse effects including irritability, drowsiness and apnea.

Researchers concluded that there is insufficient evidence to support or oppose the use of metoclopramide to treat GERD in infants, and gave an "inconclusive" recommendation for the safety and efficacy of metoclopramide in infants.

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