Duration of therapy with metoclopramide: a prescription claims data study.
OBJECTIVE
Metoclopramide-induced tardive dyskinesia is associated with cumulative drug exposure, which can result from prolonged use of the drug. We estimated therapy duration with metoclopramide, and measured the extent of therapy beyond the maximum time period of 12 weeks evaluated in the clinical trials and recommended in the label.


METHODS
Prescription claims for metoclopramide from 2002 to 2004 were extracted for participants residing throughout the US and contained within the Caremark pharmacy benefit manager (PBM) database. An episode of therapy was defined as one or a series of consecutive claims with no more than a 30-day lag between the dispensing date of a new claim and the ending date of the preceding claim. Episode duration was calculated by subtracting the start date from the end date for each episode.


RESULTS
During the study period, almost 80% of participants (total = 200 907) had only one episode of therapy. The length of the longest episode for most patients (85%) varied from 1 to 90 days, yet 15% of the patients appeared to have received prescriptions for metoclopramide for a period longer than 90 days. Cumulative therapy for longer than 90 days was recorded for almost 20% of the patients.


CONCLUSIONS
These results suggest that despite the known risk of tardive dyskinesia and the labeled recommendations on duration of metoclopramide use, many patients appear to use the drug for relatively long time periods beyond the labeled recommendations. Physicians should carefully consider the risk-benefit profile of the drug and, if possible, avoid increased risk of tardive dyskinesia due to prolonged exposure.
Kaplan
Sigal
S
Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD 20993, USA. sigal.kaplan@fda.hhs.gov
Staffa
Judy A
JA
Dal Pan
Gerald J
GJ
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage* / Q000009:adverse effects; D016208:Databases, Factual; D004334:Drug Administration Schedule; D004348:Drug Labeling; D011307:Drug Prescriptions; D004409:Dyskinesia, Drug-Induced / Q000209:etiology*; D006801:Humans; D007356:Insurance, Pharmaceutical Services / Q000706:statistics & numerical data; D008787:Metoclopramide / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000592:standards*; D012306:Risk
D000932:Antiemetics; D008787:Metoclopramide