A real-world safety evaluation of new oral anticoagulants in elderly patients: evidence from the Adverse Drug Reaction Monitoring Center of Henan Province.

Background: The use of new oral anticoagulants (NOACs) is becoming increasingly widespread, but data on their adverse reactions are still incomplete. Further analysis based on data from the Drug Adverse Reaction Center is needed to guide safe clinical use.

Methods: A retrospective analysis was performed on 281 cases of rivaroxaban and 48 cases of dabigatran etexilate-related ADR reported by medical institutions collected by a provincial Food and Drug Administration from 2018 to 2023.

Results: Of the 329 ADRs, 164 males and 165 females were reported. Among the rivaroxaban-related ADRs, 271 were administered orally, 6 were given nasogastric feeding, 2 were given tube feeding, and 2 were intravenously instilled. Among the ADRs associated with dabigatran etexilate, 48 cases were administered orally. Serious adverse drug reactions were reported in 21.6% of cases (71 out of 330). The clinical manifestations of ADR of NOACs mainly include blood in the stool, blood in the urine, bleeding gums, coagulation disorders and ecchymosis. The causal relationship between serious adverse reactions and drugs was judged to be very likely in 24, 43 cases was judged to be probable, and 4 cases were unknown.

Conclusions: Attention should be paid to the clinical use of NOACs in elderly patients, and pharmacovigilance should be strengthened, and the implementation of individualised medication regimen should be used to promote clinical safety and rational drug use.