Abstract:
OBJECTIVE To excavate the adverse drug events(ADE) signals of teriparatide and abaloparatide, and to provide reference for clinical medication safety and rational selection.
METHODS All ADE reports of teriparatide from the first quarter of 2004 to the third quarter of 2021 and abaloparatide from the launch of 2017 to the third quarter of 2021 in FAERS database were mined using reporting odds ratio(ROR) and proportional report ratio(PRR). Meanwhile, the basic information such as gender, age and severe ADE outcome of the patients were statistically reported.
RESULTS After excluding all kinds of injuries, poisoning and operation complications, all kinds of operations and medical operations, product problems and social problems and other unrelated signals, there were 88 474 ADE reports related to teriparatide, and 600 effective signals were obtained, the signals involved 22 system organs; 12 286 cases of abaloparatide-related ADE reports, 137 effective signals and 17 system organs were mined. According to the occurrence frequency, the most common ADEs for the two drugs were dizziness (4 896 cases) and headache(1 485 cases). According to the signal strength, N-telopeptide urine increased of teriparatide(ROR:135.867) and serum procollagen type I N-terminal propeptide decreased of abaloparatide(ROR:881.625) rank first, both which were not reported in the drug instructions. The ADE signals of both drugs were concentrated in musculoskeletal and connective tissue conditions, general disorders and administration site conditions.
CONCLUSION The application of teriparatide and abaloparatide have been relatively safe, and most of the common ADE are relatively mild. However, special attention should be paid to the occurrence of rare ADE. Laboratory index such as blood calcium, blood uric acid should be regularly detected, meanwhile, watch out for the occurrence of adverse reactions in the skeletal system.