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The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits.
Am J Gastroenterol 2013; 108(6):866-72AJ

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.

Authors+Show Affiliations

Department of Gastroenterology, Evanston Hospital, NorthShore University HealthSystem, Evanston, Illinois 60201, USA. ehrenpreis@gipharm.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23735907

Citation

Ehrenpreis, Eli D., et al. "The Metoclopramide Black Box Warning for Tardive Dyskinesia: Effect On Clinical Practice, Adverse Event Reporting, and Prescription Drug Lawsuits." The American Journal of Gastroenterology, vol. 108, no. 6, 2013, pp. 866-72.
Ehrenpreis ED, Deepak P, Sifuentes H, et al. The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits. Am J Gastroenterol. 2013;108(6):866-72.
Ehrenpreis, E. D., Deepak, P., Sifuentes, H., Devi, R., Du, H., & Leikin, J. B. (2013). The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits. The American Journal of Gastroenterology, 108(6), pp. 866-72. doi:10.1038/ajg.2012.300.
Ehrenpreis ED, et al. The Metoclopramide Black Box Warning for Tardive Dyskinesia: Effect On Clinical Practice, Adverse Event Reporting, and Prescription Drug Lawsuits. Am J Gastroenterol. 2013;108(6):866-72. PubMed PMID: 23735907.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits. AU - Ehrenpreis,Eli D, AU - Deepak,Parakkal, AU - Sifuentes,Humberto, AU - Devi,Radha, AU - Du,Hongyan, AU - Leikin,Jerrold B, PY - 2013/6/6/entrez PY - 2013/6/6/pubmed PY - 2013/8/24/medline SP - 866 EP - 72 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 108 IS - 6 N2 - 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. SN - 1572-0241 UR - https://www.unboundmedicine.com/medline/citation/23735907/The_metoclopramide_black_box_warning_for_tardive_dyskinesia:_effect_on_clinical_practice_adverse_event_reporting_and_prescription_drug_lawsuits_ L2 - http://Insights.ovid.com/pubmed?pmid=23735907 DB - PRIME DP - Unbound Medicine ER -