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Analyzing the adverse events of NK-1 receptor antagonists: a pharmacovigilance study from the FAERS database
Hong Pan1, Xiang Shi2, Yiguo Jiang3
1Department of Pharmacy, Wuxi No. 5 People's Hospital, Wuxi, 214007, China.
Background:
NK-1 receptor antagonists (NK-1RAs) are proven to be successful in preventing chemotherapy-induced nausea and vomiting (CINV). The safety profile of NK-1RAs has not been systematically analyzed in the real world. This pharmacovigilance study investigated the differences in adverse events (AEs) between NK-1RAs.
Methods:
Adverse events (AEs) associated with NK-1RAs were gathered and standardized using data from the FAERS database spanning from the first quarter of 2009 to the fourth quarter of 2023. Various disproportionality techniques were employed for data analysis, such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
Results:
A total of 5434AE reports listing NK-1RAs as the primary suspected drugs were identified. The System Organ Classes (SOC) appeared as significant safety signals were found. Among NK-1RAs, the most frequently reported AEs were related to general disorders and administration site conditions. In terms of PT level, the strong signals were mainly injection site reactions associated with aprepitant and fosaprepitant. Moreover, toxic encephalopathy and encephalopathy of the aprepitant were all positive with four algorithms. A significant finding was the recognition of adverse events linked to endocrine disorders, which were not previously mentioned in the medication instructions.
Conclusion:
The safety profile of NK-1RAs has been reported to be variable.If intravenous formulations were used in the clinic, injection site reactions should be a concern. In addition, more attention should be paid to the management of encephalopathy toxicity in patients treated with aprepitant in combination with ifosfamide. Besides known AEs, we have identified several new high-risk AEs, such as inappropriate antidiuretic hormone secretion, adrenal insufficiency and hyponatraemia. Overall, clinicians should closely monitor the occurrence of NK-1RA-related AEs in clinical applications.
Insights
This study analyzed real-world adverse events for NK-1 receptor antagonists (NK-1RAs), finding variable safety profiles and identifying new risks like encephalopathy and endocrine disorders. Clinicians should monitor these NK-1RA side effects closely.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Oncology Supportive Care
Background:
- Neurokinin-1 receptor antagonists (NK-1RAs) effectively prevent chemotherapy-induced nausea and vomiting (CINV).
- Real-world safety data for NK-1RAs remains incompletely characterized.
- This study aimed to systematically analyze adverse events (AEs) associated with NK-1RAs.
Purpose of the Study:
- To investigate and compare adverse event profiles of different NK-1 receptor antagonists.
- To identify potential safety signals and previously unrecognized adverse events associated with NK-1RA use.
- To provide real-world safety insights for clinicians managing patients on NK-1RAs.
Main Methods:
- Utilized the FAERS database (Q1 2009 - Q4 2023) for adverse event data.
- Employed disproportionality analyses including ROR, PRR, BCPNN, and MGPS.
- Analyzed 5434 AE reports where NK-1RAs were the primary suspected drugs.
Main Results:
- Identified significant safety signals across various System Organ Classes (SOCs).
- Frequent AEs included general disorders and injection site reactions (aprepitant, fosaprepitant).
- Detected toxic encephalopathy and new signals in endocrine disorders (e.g., SIADH, adrenal insufficiency, hyponatremia).
Conclusions:
- NK-1RA safety profiles exhibit variability, with injection site reactions a concern for IV formulations.
- Close monitoring for encephalopathy, especially with aprepitant and ifosfamide, is crucial.
- Clinicians must be vigilant for newly identified high-risk AEs like inappropriate antidiuretic hormone secretion, adrenal insufficiency, and hyponatremia.
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