Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule.
- Author:
Shan QING
1
;
Lin GAO
2
;
Li ZHANG
3
;
Jian-Ping JIA
4
;
Xin-Min LIU
5
;
Shao-Liang JI
6
;
Xiao-Hui YANG
7
Author Information
1. Guiyang Center for ADR Monitoring, Guiyang 550003, China. ronaldinho1999@163.com
2. Guiyang Center for ADR Monitoring, Guiyang 550003, China.
3. Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China.
4. The Department of Neurology, Xuan Wu Hospital Capital Medical University, Beijing 100053, China.
5. The Institute of Medicinal Plant Development, Chinese Academy of Medical Science Peking Union Medical College, Beijing 100094, China.
6. Bejing University of Chinese Medicine, Bejing 100029, China.
7. Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China.
- Publication Type:Journal Article
- MeSH:
Capsules;
economics;
China;
Drug Evaluation;
economics;
Drugs, Chinese Herbal;
adverse effects;
economics;
Female;
Humans;
Male;
Marketing;
Product Surveillance, Postmarketing;
economics
- From:
China Journal of Chinese Materia Medica
2013;38(21):3790-3794
- CountryChina
- Language:Chinese
-
Abstract:
By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.
