This widely used cold drug has been delisted, experts: detoxification and detoxification of traditional Chinese medicine injection delisting is the trend

On November 11, the State Food and Drug Administration issued an announcement and decided to stop the production, sales and use of Lianbizhi injection in China from now on, and cancel the drug registration certificate. The products that have been put on the market shall be recalled by the holder of the drug marketing authorization, and the recalled products shall be supervised and destroyed by the provincial drug supervision and management department of the place where they are located or other harmless treatment shall be taken in accordance with the law.

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"Although the safety of Chinese medicine injection has been discussed before, and it has rarely been used clinically, it still feels relatively sudden for its sudden delisting." Zhang Yatong, deputy director of the Pharmacy Department of Beijing Hospital, told the Health Times reporter that There are indeed many side effects of Lianbizhi injection, especially its damage to kidney function, and may also cause dizziness, gastrointestinal reactions, anaphylactoid reactions and other side effects.

Regarding delisting, the reason given by the State Food and Drug Administration in the announcement is that, in accordance with Article 83 of the Drug Administration Law of the People's Republic of China and other relevant provisions, the State Drug Administration organized a post-market evaluation of Lianbizhi injection, and made the above decision after evaluation. According to the reporter's understanding, the current production of the drug includes Wuxi JiyuShanhe Pharmaceutical Co., Ltd., Shenwei Pharmaceutical Group Co., Ltd., and Jiangsu Jiuxu Pharmaceutical Co., Ltd.

In 2016, Chen Guosheng, an expert at Guangzhou Tianhe District Hospital of Traditional Chinese Medicine, published in the article "Analysis of 126 Cases of Pharmacogenic Kidney Damage Caused by Lianbizhi Injection" in "Pharmacy Today", saying, "The main component of Lianbizhi injection is andrographolide and its derivative preparation, which has the effect of clearing heat, detoxification, antibacterial and anti-inflammatory, but with its wide application in the clinic, it has caused more and more reports of pharmacogenic adverse reactions (ADR). ”

The Health Times reporter noted that lianbizhi injection had been named many times before.

On April 12, 2005, the former State Food and Drug Administration issued an adverse drug reaction information circular pointing out that from 1988 to March 2005, 50 cases of Lianbizhi injection were reported in the case report database of the National Adverse Drug Reactions Monitoring Center, and the adverse reactions were manifested as acute renal function damage, rash, dizziness, gastrointestinal reactions, anaphylactoid reactions, etc. Among them, there were 17 cases of acute renal impairment, and 1 case was complicated by abnormal liver function. In 2006, the former State Food and Drug Administration revised its drug instructions again, indicating that the elderly, children, pregnant women, lactating women and patients with kidney disease should be used with caution. In the 2017 edition of the National Medical Insurance Catalogue, Lienbir injection is restricted to secondary and above medical institutions.

"The clinical treatment of injection in heat removal and detoxification has become less and less, because its risk-to-effect ratio is indeed not high, and There are many alternative drugs available for Lianbizhi injection in heat detoxification and detoxification, so it is understandable to delist." Zhang Yatong explained that the delisting of all Chinese medicine injections may be unlikely, but it may be an inevitable trend for the delisting of Chinese medicine injections for heat and detoxification.