Despite FDA black box warning, prescription of Reglan for premature infants continue

Reglan, metoclopramide never approved for use in infants

Recently, researchers have observed a disturbing trend in neonatal units across the country:  doctors prescribing Reglan -- also known by its generic name, metoclopramide -- to treat premature infants. This alarming development has raised serious concerns from many consumer safety advocates, particularly because the drug was never approved for use in infants.

Reglan (metoclopramide) was approved for short term use – no longer than three months – by the Food & Drug Administration in 1979 to treat various gastrointestinal disorders.  But in 2009, the FDA issued a black box warning, the strongest of its kind, for the drug and its generic forms, stating that the medication had "been linked to tardive dyskinesia."  In fact, Reglan (metoclopramide) has been identified as the leading cause of TD among patients with the disorder in the United States.

The increase in its use in neonatal units began about a decade ago, when the only motility agent approved for use in infants was pulled from the market for safety concerns.  It has continued to grow each year.  While those at highest risk of developing TD are women and the elderly, there are very serious concerns about the safety of treating babies with Reglan (metoclopramide), as there has never been any significant research done on the drug's effects on infant populations.  

"Although the FDA issued its black box warning last year," said Scott Nabers, of Blizzard, McCarthy & Nabers, which represents dozens of patients disabled by Reglan, "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."

Blizzard, McCarthy & Nabers recently launched the website ReglanJustice.com to provide consumers with critical information about the risks associated with Reglan (metoclopramide).