INFO - Tardive Dyskinesia and Reglan (metoclopramide) Use: Effects of Cisapride Market Withdrawal

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Tardive Dyskinesia and Metoclopramide Use: Effects of Cisapride Market

Withdrawal

Shaffer; n Butterfield; Carol Pamer; Ann Corken Mackey

Abstract and Introduction

Abstract

Objective: 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.

Design: Retrospective and observational analyses.

Setting: International metoclopramide adverse event reports and domestic

drug-use data for the continental United States.

Patients: Users of metoclopramide for 30 days or more who experienced

adverse events reported as TD.

Interventions: Analyses of the Food and Drug Administration Adverse Event

Reporting System (AERS) and IMS HEALTH data.

Main Outcome Measures: Pharmacoepidemiological patterns in AERS reports and

utilization data from IMS HEALTH.

Results: 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.

Conclusion: 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.

Introduction

Metoclopramide is a gastrointestinal prokinetic agent used in the treatment

of symptomatic gastroesophageal reflux disease and diabetic gastroparesis.

In addition, injectable metoclopramide is used to prevent nausea and

vomiting following chemotherapy and facilitate small bowel intubation and

radiological examinations. As an antidopaminergic agent, metoclopramide can

cause tardive dyskinesia (TD), a syndrome characterized by persistent,

potentially irreversible, abnormal involuntary movements.[1-3]

Risk factors for TD include increased age, female gender, prolonged

antidopaminergic drug exposure, presence of abnormal involuntary movements

before drug therapy, diabetes mellitus, " organic " brain dysfunction and

atrophy, and psychiatric disorders (e.g., schizophrenia, affective disorder,

and alcohol abuse/dependence).[4-11] Familial history is also associated

with increased risks for metoclopramide-induced TD.[12] Drugs implicated in

TD in addition to metoclopramide include antipsychotic agents,

antidepressants, central nervous system (CNS) stimulants, calcium channel

blockers, and less frequently other drugs with CNS activity (for example,

antihistamines, anticholinergics, and dopamine/serotonin

antagonists).[13-15]

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