Korean J Psychopharmacol.
2013 Oct;24(4):172-179.
Agreement of Label Information on Anxiolytics and Antidepressants for Pregnant Women: Comparison among Korea, the USA, the UK and Japan
- Affiliations
-
- 1Korea Institute of Drug Safety and Risk Management, Seoul, Korea. bjpark@drugsafe.or.kr
- 2Department of Preventive Medicine, College of Medicine, Seoul National University, Seoul, Korea.
- 3Department of Obstetrics and Gynecology, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
- 4Department of Psychiatry, School of Medicine, Wonkwang University, Iksan, Korea.
Abstract
OBJECTIVE
Anxiolytics and antidepressants are commonly used to treat depressive disorders in pregnant women. Specific and clear evidence is required when managing pregnant patients with such medications to ensure safety. However, information provided by approval label information is insufficient and often different among many countries. By analyzing label information of approval label and other references, this study aims to show the limitations and suggest appropriate directions for retrieving safety information.
METHODS
We selected five anxiolytics and eleven antidepressants, which belongs to Korea drug classification codes 117 (psychotropic agents). We chose four countries, Korea, the United States of America (USA), the United Kingdom, Japan and collected safety information for pregnant women in label information. We evaluated the safety information based on recommendation level and evidence level. Then, kappa value and overall agreement were calculated using SAS 9.3. to assess data homogeneity. We further searched Reprotox and a textbook about contraindicated drugs in label information.
RESULTS
Recommendation level and evidence level was different in each country. The number of commonly contraindicated drug in label information of four countries was none, and contraindicated drugs in labels were different respectively. Kappa value of evidence level between label information of Korea and Japan, the USA and Japan was 0.61, 0.43 respectively, corresponding to 'substantial agreement' and 'moderate agreement'. The overall agreement was 75%, 62.5% respectively. The information of label was different from that of other references, Reprotox and a textbook in terms of the clinical evidences and recommendation levels.
CONCLUSION
Safety information of anxiolytics and antidepressants in label information needs to be updated on a regular basis both for health professionals and patients. With the implication of the inconsistent guidance for the safety information in pregnant women, reliable safety information in pregnant women would be needed.
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