Reglan has been used in neonatal units for nearly a decade as a motility agent for premature infants. This replacement occurred when the only motility agent approved for infants was removed from the market. There are concerns about treating infants with Reglan because there has been no significant research performed concerning the drug’s effect on infants. All basic research performed with this drug indicate that the highest risks for Tardive Dyskenisa are women and the elderly.
Reglan has been used in short term treatment of various gastrointestinal disorders since it was approved but the FDA in 1979. Short term use falls under the guidelines of less than three months of use. In 2009 the FDA issued what is known as a black box warning (the strongest warning by the FDA) advising that Reglan and its generic forms have been linked to a tardive dyskenisia. In the United States Reglan has been named as the leading cause of TD.
“The makers of Reglan have known about the risk of tardive dyskinesia for years, but have not adequately warned doctors or the public,” stated Roger Drake, an attorney handling Reglan TD cases, “It is my hope that the black box warning will put the brakes on widespread Reglan prescriptions and curb pharmaceutical marketing schemes that harm the public.”
Although the black box warning was issued a year ago, there are still many doctors and patients who are unaware of the significant risks that Reglan can cause. Because of the many years that Reglan had been on the market, doctors assume that it is a safe drug and continue to prescribe it for the recommended use as well as various off label uses such as to treat premature infants.
Reglan helps the passage of food through the stomach and small intestine by increasing the contractions of these organs. Reglan is used for many different symptoms of gastrointestinal distress including heartburn, reflux, nausea prevention and cessation of vomiting. With a short list of side effects and proven effectiveness with short term use Reglan seems to be an ideal medication. However, with the link to TD, and an FDA black box warning, it is important to learn as much as possible about the effects of Reglan on all patients, but especially premature infants whose bodies are frail.
The FDA has never approved Reglan for use in infants and the spike in the use of this drug is causing alarm for researchers and people who are aware of the dangers of Reglan and TD. This calls for research about the effect of Reglan on infants, and the other possible used for this drug, in order to get it approved for use in these cases.