Although a black box warning for tardive dyskinesia was announced by the FDA in February 2009, lawsuits filed against the makers of Reglan (metoclopramide) allege the drug companies knew for decades that the risk of movement disorders was much greater than acknowledged in previous labels.
According to an expert witness report filed in a Georgia lawsuit by Dr Robert Nelson, a former 20-year employee of the FDA and National Institute of Health, "the 1/500 EPS labeling was inaccurate and misleading from the moment the oral dosage form was approved."
In citing a 2008 study on the causes of TD at a university-based movement disorder clinic, Nelson reports that from 2000-2006, metoclopramide induced TD "was more common than any other cause, accounting for 34.5%" of all cases, or 87 out of 250.
Reglan is approved only for the short term treatment (12 weeks max) of gastroesophageal reflux disease (GERD), in adults who have not responded to other therapies, and for diabetic gastroparesis, for two to 8 weeks.
In the February 2009, letters notifying the drug makers of a need for a black box, the FDA stated, "we have become aware of continued spontaneous reports to the FDA of tardive dyskinesia associated with metoclopramide use. Exposure greater than 12 weeks was evident in a majority of these reports."
In fact, a telephone survey conducted, by then Reglan maker (AH Robins), back in 1985, "found that 38% of Reglan users took the drug for between one and two years and another 46% of Reglan users took the drug for three to six months," Dr Bob West, a pharmacologist and toxicoligist, says in a report filed in a Louisiana lawsuit.