J Pharmacoepidemiol Risk Manage.
2022 Sep;14(2):144-148. 10.56142/jperm.22.0012.
Lactic Acidosis Adverse Drug Reaction Reporting Aspect Evaluation of Hepatitis B Treatment Using Korea Adverse Event Reporting System
- Affiliations
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- 1Department of Pharmacy, Inha University Hospital, Incheon, Korea
- 2Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Medical Center, Seoul, Korea
- 3Department of Life and Nanopharmaceutical Sciences, Graduate School, Kyung Hee University, Seoul, Korea
- 4College of Pharmacy, Dongduk Women’s University, Seoul, Korea
- KMID: 2534685
- DOI: http://doi.org/10.56142/jperm.22.0012
Abstract
- Chronic hepatitis B is caused by the hepatitis B virus and is known as a major cause of chronic liver disease with a high worldwide prevelance. And it has a risk of developing complications such as cirrhosis and hepatocellular carcinoma. Oral nucleos(t)ide analogues, known as first-line drugs for the treatment of chronic hepatitis B, are relatively well tolerated. However, sometimes it can cause mitochondrial hypofunction and result in lactic acidosis. Therefore, voluntary reporting of lactic acidosis, which can progress to fatal disease, and spontaneous reporting of lactic acidosis related symptoms were comparatively analyzed. In this study, by using Korea Adverse Event Reporting System Database, the cases reported as lactic acidosis (group 1) or lactic acidosis related symptoms (group 2) were compared to examine the pattern of adverse event reporting of nucleos(t)ide analogues. As a result, there was no statistically significant difference between the two groups in gender (p-value = 0.657) and age (p-value = 0.5092). In addition, when the usage of drugs of the two groups were compared, similar patterns were found. The review and analysis of the status of reports suggests that appropriate attention needs to be paid to the relevant side effects of lactic acidosis.
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