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J Am Pharm Assoc (2003). 2004 Nov-Dec;44(6):661-5.

Tardive dyskinesia risks and metoclopramide use before and after U.S. market withdrawal of cisapride.

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Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20857, USA.



To assess risk factors for tardive dyskinesia (TD) in spontaneous reports of metoclopramide and TD and evaluate metoclopramide prescribing patterns before and after withdrawal of cisapride from the market in the United States.


Retrospective and observational analyses.


International metoclopramide adverse event reports and domestic drug-use data for the continental United States.


Users of metoclopramide for 30 days or more who experienced adverse events reported as TD.


Analyses of the Food and Drug Administration Adverse Event Reporting System (AERS) and IMS HEALTH data.


Pharmacoepidemiological patterns in AERS reports and utilization data from IMS HEALTH.


The case series comprised 87 reports of primarily older (mean+/-SD, 60+/-22 years ) women (67% of all cases). While average metoclopramide daily dose (33+/-14 mg) was within recommended product labeling limits, duration of use was considerably longer (753+/-951 days). Overall, 37% of the reports included concomitant drugs believed to be TD risk factors. Similarly, 18% of the reports noted comorbid diseases that are considered risk factors for development of TD. Metoclopramide utilization decreased following cisapride marketing in 1993 and increased following cisapride withdrawal in 2000. The majority (62%) of metoclopramide prescriptions were intended for women. Intended use overall increased with age and was highest in the seventh and eighth decades, with nearly one quarter of all utilization being in persons older than 70 years.


Well-described TD risk factors were common in metoclopramide-associated TD reports. Given the cisapride market withdrawal and associated increased metoclopramide utilization, the incidence of TD may increase accordingly. TD risk factors relative to the intended benefit and duration of use should be considered in metoclopramide prescribing.

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[Indexed for MEDLINE]

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