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

Domperidone is a dopamine antagonist used for the symptomatic management of nausea and vomiting. Many countries banned or add a black box warning due to an increased risk of serious adverse cardiac effects. In 2014, the Korea Ministry of Food and Drug Safety also released a safety warning to carefully consider adverse cardiac effects when prescribing domperidone. Therefore, we conducted this study to analyze the impact of the safety warning on domperidone prescribing. This study included patients 65 years or older who used national health insurance services in the years 2011 and 2016, using the national patient sample dataset in South Korea. We analyzed the characteristics of domperidone prescribing and compared on pre- and post-safety warning. Prescribing frequency of domperidone was significantly reduced from 603,962 cases in 2011 to 24,623 cases in 2016. In 2011, 53,272 (8.8%) prescriptions were for greater than 30 mg/day, whereas only 200 (0.8%) prescriptions were in 2016. The number of patients with one or more comorbidities and electrocardiogram monitoring showed positive changes after the safety warning. In conclusion, after the 2014 safety letter was issued, domperidone was more safely prescribed in various aspects in elderly patients, including frequency of prescribing, maximum daily dose, and duration of continuous prescription.