Domperidone Prescribing Practices Exposed Patients to Cardiac Risk despite a “Black Box” Warning: A Canadian Tertiary Care Center Study

Abstract

Background. In 2012, Health Canada released a warning regarding domperidone use, based on associations with life-threatening arrhythmias and death. Objective. This study aimed to compare the appropriateness of domperidone prescribing patterns before the advisory to those afterward. Methods. Two retrospective reviews were conducted for patients prescribed domperidone during quarters in 2005 and 2012. Outcomes included appropriateness of indication, dosing regimens, monitoring of electrolytes, baseline electrocardiogram performance and characteristics, presence of left ventricular dysfunction, and coprescription of QT-prolonging medications. Univariable and multivariable logistic regression analyses were performed. p values < 0.05 were considered significant. Results. 290 and 287 patients were analyzed in 2005 and 2012, respectively. Domperidone initiation in hospital decreased from 2005 to 2012 (71.4% versus 39.4%, p < 0.0001) as did prescriptions for nonapproved indications (84.8% versus 58.2%, p < 0.0001). In-hospital initiation predicted prescription for nonapproved indications (OR = 7.01, 95% CI 4.52–10.87, p < 0.0001). Use of domperidone as the sole GI drug predicted nonapproved indications (OR = 2.51, 95% CI 1.38–4.55, p = 0.002). Conclusions. The advisory was associated with more appropriate domperidone initiation and compliance with recommended dosages. Our study suggests the need for increased awareness of the dosing and monitoring of domperidone to ensure patient safety.

Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis

“…Hospital settings were heterogenous, including an emergency department, various clinical units including general medicine, cardiology and psychiatry and there was one inpatient headache centre. Many studies did not describe the specific location of hospital care, rather describing patients in other ways such as “total hospital population” [ 19 ], “medically ill and/or hospitalised inpatients” [ 20 , 21 ], “inpatients” [ 22 , 23 ] and “admitted patients” [ 24 ].…”

Domperidone and the risks of sudden cardiac death and ventricular arrhythmia: A systematic review and meta‐analysis of observational studies

“…In some jurisdictions, alternatives to domperidone such as proton‐pump inhibitors or metoclopramide for diabetic gastroparesis are available 38 . However, prescriptions for domperidone in special populations remain prominent given the lack of therapeutic alternatives.…”

Impact of Safety Warning on Domperidone Prescribing for Geriatric Patients in South Korea: Analysis of National Insurance Claim Data

“…With this longer time period, more physicians could have noticed and heeded the regulatory actions. In another comparative study of domperidone use in a Canadian tertiary care center, the rate of domperidone initiation in the hospital decreased from 71.4% to 39.4% after a safety warning was issued by Health Canada [32]. This warning reduced domperidone use for non-proven indications, prescriptions for doses >30 mg/day, and for patients older than 60.…”