On January 11, the State Food and Drug Administration issued an announcement to stop the production, sale and use of Libizhi injection in China and cancel the drug registration certificate.
According to the announcement, in accordance with Article 83 of the Drug Administration Law of the People's Republic of China and other relevant provisions, the State Food and Drug Administration organized a post-market evaluation of Lianbizhi injection. After evaluation, the State Food and Drug Administration decided to stop the production, sales and use of Lotus Bizhi 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.
It is reported that the composition of Lianbizhi injection is sodium bisulfite andrographolide, which has the effect of clearing heat, detoxification, antibacterial and anti-inflammatory, and is clinically used for the treatment of bacterial dysentery, pneumonia and acute tonsillitis, and the route of administration is intramuscular injection and intravenous infusion.
According to the "Adverse Drug Reaction Information Circular" issued by the State Food and Drug Administration in 2005, from 1988 to March 2005, 50 cases of Case Reports related to Libizhi Injection were reported in the case report database of the National Adverse Drug Reaction Monitoring Center, and the adverse reactions were manifested as acute renal function damage, rash, dizziness, gastrointestinal reactions, allergic-like reactions, etc. Among them, there were 17 cases of acute renal impairment, and 1 case was complicated by abnormal liver function. From 1978 to February 2005, a total of 26 cases of acute renal impairment caused by Libizhi injection were retrieved in domestic literature reports.
News extension
Compound andrographis tablets, bovine yolk detoxification tablets...
A batch of commonly used drugs was discontinued and recalled
Recently, the Sichuan Provincial Drug Administration released
Notice of non-compliance with 15 batches of drugs
Included in the announcement
Compound andrographis tablets, bovine yolk detoxification tablets and other commonly used drugs
Hurry up and check it out
Your little medicine box has not been tricked
The following is a list of non-compliant drugs
For the above-mentioned drugs that do not comply with the regulations
The drug supervision and administration department has requested
Relevant businesses and units take
Suspension of sales use, recalls, etc
Risk control measures
For reasons of non-compliance
Conduct investigations and carry out practical rectification
If you have these medicines at home
Remember to carefully check the medicines at home
Product name, production enterprise, production batch number and other information
Don't be careless
Source: State Drug Administration, Sichuan Provincial Drug Administration, etc