OBJECTIVE  To analyze the differences in pediatric medication information in the instructions for new anti-seizure medications commonly used in children between China, the United States, and Europe, this provides a reference for improving the pediatric medication information in the instructions.

METHODS  The drug instructions approved by drug supervision and administration departments in China, the United States and Europe were collected, and the information about children's medication in the drug instructions was statistically analyzed.

RESULTS  A total of 127 drug package inserts were collected. The labeling rate of pediatric medication information showed little difference in indications, dosage and administration, precautions, and pediatric medication use; clinical trials in the United States were significantly higher than those in China(OR=31.31, P<0.05), and adverse reactions and pharmacokinetics in European drug package inserts were significantly higher than those in China(OR=0.13, P<0.05; OR=0.17, P<0.05). Although the labeling rate of indications for children in drug instructions was similar both domestically and internationally, the age range for children approved for use and the types of seizures approved were more extensive in the United States and Europe. The labeling rate of excipients in drug package inserts was 100.00% in the United States and Europe, and 57.58% in China.

CONCLUSION  The labeling rate of pediatric medication safety data in the instructions for new anti-seizure medications commonly used in children is significantly higher abroad than in China. The pediatric indications in China’s drug instructions are insufficient compared to foreign countries in terms of both seizure forms and applicable age ranges. The labeling rate of excipients in China is significantly lower than that in foreign countries, and there is a need to further promote the improvement of pediatric medication information in drug instructions.