A comparative study of different references to the fetal risk of drugs in pregnancy_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Chuan ^1,2 ,  ZHANG Lingli ^1,2 , ZENG Linan ^1,2 , WANG Xiaodong ^2,3 , JIANG Hongyan ⁴

1. Evidence-Based Pharmacy Center, Sichuan University, Chengdu 610041, P.R.China;
2. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Chengdu 610041, P.R.China;
3. Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, P.R.China;
4. West China School of Pharmacy, Sichuan University, Chengdu 610041, P.R.China;

Corresponding?author：

ZHANG Lingli, Email: zhlingli@scu.edu.cn

Keywords：

Fetal risk; Drugs in pregnancy; Risk classification system

DOI：

10.7507/1672-2531.201812027

Video：

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Objective This study aims to compare different references for the fetal risk of drugs used in pregnancy to provide evidence for the safety of drug use in pregnancy.Methods Four drug databases, including Lexicomp, Micromedex, TERIS, and Reprotox, as well as two books of drugs in pregnancy edited by Briggs and Schaefer, were searched. Descriptive analysis was performed regarding the definition of pregnancy recommendations and the specific content of medication.Results The six references employed slightly different approaches to drugs in pregnancy, however, all of them included summaries of the risk in pregnancy, data of crossing the placenta, and human and animal data. The databases of Micromedex, TERIS, and a book edited by Briggs had their risk classification systems for drug use during pregnancy. For specific drugs, the summary of different information in pregnancy was different, the amount and content of listed evidence varied, and there was no evaluation of the quality and relevance of evidence among the references.Conclusions There is no consensus on the risk assessment of drugs in pregnancy. Risk classification systems for drugs in pregnancy are still an important method for determining the fetal risk of drugs. The existing references merely list studies of drugs in pregnancy, without comprehensive quality assessment. A methodological study of assessment of the risk of drugs in pregnancy is required.

Citation： ZHANG Chuan, ZHANG Lingli, ZENG Linan, WANG Xiaodong, JIANG Hongyan. A comparative study of different references to the fetal risk of drugs in pregnancy. Chinese Journal of Evidence-Based Medicine, 2020, 20(7): 776-781. doi: 10.7507/1672-2531.201812027 Copy

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14.	Vandenbroucke JP. Thalidomide: an unanticipated adverse effect. JLL Bulletin: Commentaries on the history of treatment evaluation. Available at: http://www.Jameslindlibrary.org/illustrating/articles/thalidomide-an-unanticipated-adverse-effect.
15.	The Joanna Briggs Institute. Joanna Briggs institute reviewers' manual: 2016 edition. Adelaide: The Joanna Briggs Institute, 2016.
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22.	Mitchell AA. Studies of drug-induced birth defects. Pharmacoepidemiology (5th ed). Chichester: John Wiley & Sons, 2012: 487-504.

1. 張川, 張伶俐, 林蕓竹, 等. 妊娠期用藥調查研究的系統評價. 中國藥學雜志, 2012, 47(11): 858-862.
2. Riley LE, Cahill AG, Beigi R, et al. Improving safe and effective use of drugs in pregnancy and lactation: workshop summary. Am J Perinatol, 2017, 34(8): 826-832.
3. Ramoz LL, Patel-Shori NM. Recent changes in pregnancy and lactation labeling: retirement of risk categories. Pharmacotherapy, 2014, 34(4): 389-395.
4. 張川, 張伶俐, 王曉東, 等. 全球妊娠期用藥危險性分級系統的比較分析. 中國藥學雜志, 2016, 51(3): 234-238.
5. FDA. Pregnancy and lactation labeling (drugs) final rule. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm.
6. Briggs G. Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk (11th Ed). Washington: Lippincott Williams & Wilkins (LWW), 2017.
7. Schaefer C. Drugs during pregnancy and lactation (Third Ed). Pittsburgh: Academic Press, 2015.
8. Mitchell AA, Gilboa SM, Werler MM, et al. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol, 2011, 205(1): 51.
9. Broussard CS, Frey MT, Hernandez-Diaz S, et al. Developing a systematic approach to safer medication use during pregnancy: summary of a centers for disease control and prevention--convened meeting. Am J Obstet Gynecol, 2014, 211(3): 208-214.
10. Lie L, Shetty V, Gupta K, et al. Exploring the design and role of mobile apps for healthcare providers to find teratogenic information. AMIA Annu Symp Proc, 2017: 1100-1109.
11. 山丹, 譯. 孕期與哺乳期用藥指南(第二版). 北京: 科學出版社, 2010.
12. 楊慧霞, 段濤. 妊娠期與哺乳期用藥(第 7 版). 北京: 人民衛生出版社, 2008.
13. Hauben M, Aronson JK. Gold standards in pharmacovigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore. Drug Saf, 2007, 30(8): 645-655.
14. Vandenbroucke JP. Thalidomide: an unanticipated adverse effect. JLL Bulletin: Commentaries on the history of treatment evaluation. Available at: http://www.Jameslindlibrary.org/illustrating/articles/thalidomide-an-unanticipated-adverse-effect.
15. The Joanna Briggs Institute. Joanna Briggs institute reviewers' manual: 2016 edition. Adelaide: The Joanna Briggs Institute, 2016.
16. Gagnier JJ, Kienle G, Altman DG, et al. The CARE guidelines: consensus-based clinical case report guideline evelopment. J Diet Suppl, 2013, 10(4): 381-390.
17. 楊華, 魏晶, 王嘉仡, 等. 藥品不良反應/事件報告評價方法研究. 中國藥物警戒, 2009, 6(10): 581-584.
18. Wells G, Shea B, O'Connell D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in metaanalyses, 2010. Available at: http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.
19. Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health, 1998, 52(6): 377-384.
20. Adam MP, Polifka JE, Friedman JM. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet, 2011, 157C(3): 175-182.
21. TERIS. The Teratogen Information System. Available at: http://depts.washington.edu/terisdb/index.html.
22. Mitchell AA. Studies of drug-induced birth defects. Pharmacoepidemiology (5th ed). Chichester: John Wiley & Sons, 2012: 487-504.

Chinese Journal of Evidence-Based Medicine

A comparative study of different references to the fetal risk of drugs in pregnancy

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