Adverse Drug Reaction Reports Regarding Abnormal Behavior After Oseltamivir Use in Children as Reported by Consumers or Healthcare Professionals

Abstract

Purpose

The purpose of this study was to assess the differences between consumer (patient) and healthcare professional submissions of adverse drug reaction (ADR) reports associated with certain antiviral treatments in children.

Material and Methods

We extracted ADR reports for children aged <20 years who received oseltamivir or similar drugs (zanamivir and amantadine) between April 2004 and May 2020 from the Japanese Adverse Drug Event Report database. Abnormal behavior after oseltamivir administration was reported frequently in the news in November 2005, and a Dear Healthcare Professional letter about abnormal behavior after oseltamivir use was issued on March 20, 2007. We compared the number of ADR reports by three periods: (1) before the news, (2) between the news and the letter, and (3) after the letter. These reports were tabulated and analyzed after stratification according to the reporter (healthcare professionals only, patients and healthcare professionals, patients only), patient age (<10 years, 10–19 years), and ADR (abnormal behavior, other ADRs).

Results

For the reports from healthcare professionals only, the number of reports per quarter associated with oseltamivir was largest during the period between the news about abnormal behavior after oseltamivir use and publication of the Dear Healthcare Professional letter. The reports from patients only about abnormal behavior after oseltamivir use were first reported after publication of the letter. The proportions of reports from patients only about abnormal behavior with oseltamivir were 81.0% and 92.2% for ages <10 and 10–19 years, respectively. A ripple effect of increasing reports was observed with zanamivir or amantadine.

Conclusion

Reports from patients only might increase in response to the media more than reports from healthcare professionals only or patients and healthcare professionals do. The ADR reports from patients must be carefully assessed from the perspective of when they were reported.

Keywords:

• children
• oseltamivir
• drug safety
• spontaneous reporting system
• pharmacovigilance

Abbreviations

ADR, adverse drug reaction; JADER, Japanese Adverse Drug Event Report; MedDRA^®/J, the Japanese version of the Medical Dictionary for Regulatory Activities; PMDA, Pharmaceutical and Medical Devices Agency; PT, preferred term.

Acknowledgments

This research was supported by the Research on Regulatory Harmonization and Evaluation of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, Cosmetics from the Japan Agency for Medical Research and Development (20mk0101143h0002), and the Japan Society for the Promotion of Science (JSPS) (19K07213). We would like to thank The Charlesworth Author Services for English language editing.

Disclosure

The authors report no conflicts of interest in this work.