Results of a Post-marketing Surveillance Study on a Switch OTC Product and Information Providing for Appropriate Use

Yoshio Wada; Yoshitaka Mori; Reiko Iwabuchi; Noriko Inoue; Satoshi Takita; Kazuya Omura; Tsunenobu Uda

doi:10.11256/jjdi.12.168

Note

Results of a Post-marketing Surveillance Study on a Switch OTC Product and Information Providing for Appropriate Use

Yoshio Wada, Yoshitaka Mori, Reiko Iwabuchi, Noriko Inoue, Satoshi Takita, Kazuya Omura, Tsunenobu Uda

Author information

Yoshio Wada
Safety Management Department Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters Eisai Co., Ltd.
Yoshitaka Mori
Safety Management Department Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters Eisai Co., Ltd.
Reiko Iwabuchi
Safety Management Department Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters Eisai Co., Ltd.
Noriko Inoue
Safety Management Department Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters Eisai Co., Ltd.
Satoshi Takita
Safety Management Department Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters Eisai Co., Ltd.
Kazuya Omura
Safety Management Department Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters Eisai Co., Ltd.
Tsunenobu Uda
Safety Management Department Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters Eisai Co., Ltd.

Keywords: azelastine hydrochloride, Post Marketing Surveillance (PMS), HIGURD
®, Skainar AL, appropriate use

JOURNAL FREE ACCESS

2011 Volume 12 Issue 4 Pages 168-172

DOI https://doi.org/10.11256/jjdi.12.168

Details

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.

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