The Metoclopramide Black Box Warning for Tardive Dyskinesia: Effect on Clinical Practice, Adverse Event Reporting, and Prescription Drug Lawsuits

@article{Ehrenpreis2013TheMB,
  title={The Metoclopramide Black Box Warning for Tardive Dyskinesia: Effect on Clinical Practice, Adverse Event Reporting, and Prescription Drug Lawsuits},
  author={Eli Daniel Ehrenpreis and Parakkal Deepak and Humberto Sifuentes and R. Nithya Devi and Hongyan Du and Jerrold Blair Leikin},
  journal={The American Journal of Gastroenterology},
  year={2013},
  volume={108},
  pages={866-872}
}
OBJECTIVES:We examined the effects of the black box warning about the risk of tardive dyskinesia (TD) with chronic use of metoclopramide on management of gastroparesis within a single clinical practice, and on reporting of adverse events.METHODS:Medical records of gastroparesis patients were evaluated for physician management choices. The FDA Adverse Event Reporting System (FAERS) was analyzed for event reports, and for lawyer-initiated reports, with metoclopramide from 2004 to 2010. Google… CONTINUE READING

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