Food and Drug Administration： Special inspection will be conducted on products containing aristolochic acid

　　Xinhua News Agency, Beijing, October 31 (Reporter Chen Cong) Recently, the hot discussion on the correlation between aristolochic acid and liver cancer has aroused public concern. A spokesman for china food and drug administration responded that the safety of aristolochic acid is directly related to public health and the development of Chinese medicine. The food and drug supervision department will further strengthen supervision, conduct special inspections on products containing aristolochic acid on the market, strengthen inspection and testing, and severely crack down on illegal production and business operations.

　　A spokesperson of the Food and Drug Administration told the media a few days ago that there is no direct strong data to support the direct correlation between aristolochic acid and liver cancer, but aristolochic acid has obvious nephrotoxicity, which can cause renal tubular function damage and even lead to kidney cancer. In view of this, China has taken a series of risk control measures since 2003, and the number of cases of aristolochic acid renal damage has dropped significantly, and no reports of direct renal cancer have been received.

　　It is understood that not all aristolochic plants contain aristolochic acid, and the roots and rhizomes of aristolochic acid medicinal materials contain almost no aristolochic acid. Earlier in China, the medicinal parts have been adjusted, and the medicinal parts of the Aristolochiaceae plant Asarum have been changed from whole grass to roots and rhizomes. In addition, the use of Aristolochia manshuriensis, Radix Stephaniae Tetrandrae and Radix Aristolochiae with high aristolochic acid content has been banned in China, and it is clear that the varieties of oral Chinese patent medicines containing Aristolochia are strictly managed according to prescription drugs.

　　The Food and Drug Administration reminds patients that drugs should be used in strict accordance with doctors’ prescriptions and doctor’s orders, and pay attention to the nephrotoxicity and carcinogenic risks of drugs containing Aristolochia. No medicine can be taken in large doses for a long time.

　　The spokesman stressed that ensuring drug safety is the main responsibility of enterprises. All enterprises that use medicinal materials containing aristolochic acid as raw materials to produce preparations should evaluate the safety of their products and provide evaluation conclusions within a time limit. If they fail to provide evaluation conclusions within the time limit, they should stop production and cancel the drug approval number; If there is an evaluation conclusion, it is necessary to put forward risk control measures. After the evaluation by the Drug Evaluation Center, the instructions will be revised and improved, and the risks will be eliminated.

　　According to reports, the Food and Drug Administration will further strengthen the basic research of proprietary Chinese medicines, carry out epidemiological investigations on the use of related medicinal materials and proprietary Chinese medicines, systematically analyze the cases of liver injury in the national adverse drug reaction monitoring data, and organize technical institutions and experts to conduct risk assessment on medicinal materials and proprietary Chinese medicines containing aristolochic acid, and study and adopt risk control measures such as careful use, restricted use and discontinuation.