Results of a Post-marketing Surveillance Study on a Switch OTC Product and Information Providing for Appropriate Use
10.11256/jjdi.12.168
- VernacularTitle:新一般用医薬品の製造販売後調査結果と適正使用のための情報提供
- Author:
Yoshio Wada
;
Yoshitaka Mori
;
Reiko Iwabuchi
;
Noriko Inoue
;
Satoshi Takita
;
Kazuya Omura
;
Tsunenobu Uda
- Publication Type:Journal Article
- Keywords:
azelastine hydrochloride;
Post Marketing Surveillance (PMS);
HIGURD
®
Skainar AL;
appropriate use
- From:Japanese Journal of Drug Informatics
2011;12(4):168-172
- CountryJapan
- Language:Japanese
-
Abstract:
Objective: To investigate frequency of adverse drug reactions (ADR) on HIGURD ®
, a switch OTC product of azelastine hydrochloride, in a three-year post-marketing surveillance study.
Methods: We conducted two surveys in this study a solicited survey with a questionnaire and a survey of spontaneous ADR reports.
Results: A total of 183 cases with 293 ADRs were reported in the solicited survey on 3,453 consumers and a total of 29 cases with 37 ADRs were reported from spontaneous sources. No serious ADRs were reported. Most frequently reported ADRs were somnolence, thirst, malaise, and dysgeusia, all of which are common on azelastine hydrochloride. This study indicated that HIGURD ®
is well tolerated.
Conclusion: This study suggested that efficacy and safety of HIGURD ®
depend on how much consumers understand the contents of “Precautions for Use” section of package insert. It is considered to be effective for safety assurance in an early post-marketing phase that pharmacists inform consumers about appropriate use of HIGURD ®
and ask for the occurrence of ADRs.
