Risks of Kangfuxiaoyan suppository due to routes of administration

doi:10.19803/j.1672-8629.20220443

Abstract

Abstract: Objective To analyze the risk of Kangfuxiaoyan suppository related to routes of administration in order to provide reference for clinical rational drug use. Methods The cases of adverse drug reactions (ADR) reported in the national ADR monitoring system , related domestic literature, and precautions taken in China were summarized. The risks of Kangfuxiaoyan suppository due to vaginal administration were analyzed. Results A total of 1 916 cases of ADR related to Kangfuxiaoyan suppository were collected from the national adverse drug reaction monitoring system between 2004 and 2022. Kangfuxiaoyan suppository should have been administered rectally, but there were 215 cases of ADR caused by vaginal administration. The incidence of pain at the site of application, vulvovaginal pruritus, vulvovaginal discomfort, vulvovaginal burning sensation and allergic reactions was higher in these cases of ADR. Vaginal administration could affect the efficacy and cause such adverse reactions as vaginal irritation. Conclusion The drug label of Kangfuxiaoyan suppository has been upgraded under the requirement of National Medical Products Administration(NMPA). Drug marketing authorization holders should communicate more with health care providers and patients to control the safety risks related to vaginal administration of Kangfuxiaoyan suppository.

Key words: Kangfuxiaoyan suppository, rectal suppository, vaginal administration, adverse drug reaction, regulatory measures

CLC Number:

R994.11

ZHU Lan, JIN Zhe, LIU Lihong, ZHONG Lumiao, LIUXiaojun. Risks of Kangfuxiaoyan suppository due to routes of administration[J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 306-310.

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