Continued Use of Medications Withdrawn Internationally for Safety Concerns: Insights from an Urban Employed...

Some drugs approved for marketing are later withdrawn in other countries due to safety concerns. This study aimed to examine the use of such drugs in China and explore factors associated with continued prescribing.

A 5% random sample of the Urban Employee Basic Medical Insurance (UEBMI) database (2019-2021) from a province in China was used. Withdrawn drugs were identified from two global databases, the Onakpoya dataset and the WITHDRAWN 2.0 database that included withdrawals from 1950 to 2020. Generalized linear mixed models incorporating hospital random effects were applied, adjusting for individual-level covariates (age, sex, ethnicity, occupation, and supplementary public servant medical benefits) and institution-level covariates (medical institution level, hospital ownership and type, and region of treatment).

We included 293,859 insured individuals, of whom 16,510 (5.62%) received at least one withdrawn drug. Thirty-eight such drugs were prescribed, 26 of which remained available without restriction in China. Overall use declined from 6.21% in 2019 to 5.46% in 2021. Mean per-person spending on withdrawn drugs declined from 402.88 yuan in 2019 to 258.36 yuan in 2021. The reductions in usage and spending were mainly observed in inpatient prescribing. Nervous system medications were most frequently used (27.3% of outpatient and 52.2% of inpatient uses) and accounted for the largest share of expenditures (40.3%). Greater use was observed among men, retirees, and those with supplementary public servant medical benefits, as well as in tertiary, private, and general hospitals.

Drugs withdrawn internationally for safety concerns continued to be prescribed in China, despite overall declines in use. Efforts to strengthen post-marketing surveillance, improve alignment between domestic regulatory actions and global safety evidence, and enhance prescribing oversight-particularly in higher-level hospitals-may help reduce avoidable patient exposure to unsafe medications.