The metoclopramide black box warning for tardive dyskinesia

Effect on clinical practice, adverse event reporting, and prescription drug lawsuits

Eli D. Ehrenpreis, Parakkal Deepak, Humberto Sifuentes, Radha Devi, Hongyan Du, Jerrold B. Leikin

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

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 Scholar was searched for court opinions against metoclopramide manufacturers.RESULTS:Before the black box warning, 69.8% of patients received metoclopramide for gastroparesis, compared with 23.7% after the warning. Gastroenterologists prescribed domperidone more often after than before the warning. Metoclopramide prescriptions decreased after 2008. Adverse event reporting increased after the warning. Only 3.6% of all FAERS reports but 70% of TD reports were filed by lawyers, suggesting a distortion in signal. Forty-seven legal opinions were identified, 33 from 2009-2010. CONCLUSIONS:The black box warning for metoclopramide has decreased its usage and increased its rate of adverse event reporting. Lawyer-initiated reports of TD hinder pharmacovigilance.

Original languageEnglish (US)
Pages (from-to)866-872
Number of pages7
JournalAmerican Journal of Gastroenterology
Volume108
Issue number6
DOIs
StatePublished - Jun 1 2013

Fingerprint

Drug Labeling
Metoclopramide
Prescription Drugs
Gastroparesis
Lawyers
Domperidone
Pharmacovigilance
Medical Records
Prescriptions
Tardive Dyskinesia
Physicians

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

The metoclopramide black box warning for tardive dyskinesia : Effect on clinical practice, adverse event reporting, and prescription drug lawsuits. / Ehrenpreis, Eli D.; Deepak, Parakkal; Sifuentes, Humberto; Devi, Radha; Du, Hongyan; Leikin, Jerrold B.

In: American Journal of Gastroenterology, Vol. 108, No. 6, 01.06.2013, p. 866-872.

Research output: Contribution to journalArticle

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