In recent news, there has been a trend for doctors in neonatal units across the United States to prescribe metoclopramide — brand name Reglan — to treat premature infants for gastrointestinal disorders. This has lead to serious concerns from consumer safety groups. Specifically of concern is the fact that Reglan has never been approved for use in infants.
Reglan was approved for very short term uses by the FDA, with terms limited to no more than three months. It was approved in 1979 for the treatment of gastric disorders. However, the FDA issued a black box warning in 2009, stating that Reglan and its generic forms had been linked to tardive dyskinesia (TD), a disorder that involves involuntary movements, especially of the lower face. A black box warning is the strongest sanction the FDA can impose on a medication. Further studies have showed Reglan is the leading cause of TD among patients who have the disorder in the USA.
Prescription of metoclopramine in neonatal units began approximately 10 years ago, when the only other medicine available was pulled for safety reasons. Those most at risk of developing TD are the elderly and women, but there are concerns about Reglan’s effect on infants. There has never been a major study done on Reglan’s impact on children, which makes researchers nervous.
According to one attorney, “many doctors and patients are still not aware of the significant risks associated with its use. Because Reglan has been on the market for over 30 years, many physicians assume the drug is safe and prescribe it for various off-label uses. Perhaps the most troubling of these is its use to treat premature babies whose bodies are already extremely frail.”
An off-label use is any use of a drug outside its primary function, such as the use of Tramadol to treat restless leg syndrome instead of as a painkiller.