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How does the Food and Drug Administration respond to the cancer-causing aristolochic acid in traditional Chinese medicine?

On October 18, an American magazine published an article titled "Aristolochic acid and its derivatives are associated with liver cancer in Taiwan and other parts of Asia." Through sequencing analysis of liver cancer samples, It was found that 78% of the 98 samples from Taiwan had molecular signatures, or "fingerprints," of aristolochic acid-induced mutations.

In addition, 19% of 26 samples from Vietnam contained aristolochic acid "fingerprints", while 56% of 9 samples from other Southeast Asian countries had aristolochic acid "fingerprints". Based on the analysis of more than 1,400 liver cancer samples worldwide, researchers believe there is a "decisive association" between aristolochic acid and liver cancer.

Recently, a spokesman for the State Food and Drug Administration responded to this matter, saying that based on large epidemiological samples and big data analysis, liver cancer patients in my country are mainly caused by hepatitis B virus infection. Is it related to aristolochic acid? There is a direct relationship, but there is no direct and strong data support.

At present, my country has taken measures to prevent the risks of drugs containing aristolochic acid. A spokesman for the Food and Drug Administration said that not all Aristolochiaceae plants contain aristolochic acid. Since 2003, my country has adopted a series of risk control measures for aristolochic acid-containing medicinal materials and Chinese patent medicines, including:

1. Prohibiting the use of Guanmutong and Guangfangjihe with high aristolochic acid content Aokiphylla;

2. Adjust the medicinal parts of the medicinal materials. Change the medicinal parts of the Aristolochaceae plant Asarum from the whole plant to the roots and rhizomes. The roots and rhizomes contain almost no aristolochic acid;

3. Clear safety warnings, and strictly manage oral proprietary Chinese medicines containing Aristolochia medicinal materials as prescription drugs; formulate "Principles for Handling Chinese Medicines Containing Toxic Materials and Other Safety Issues".

After taking the above measures, the number of cases of kidney damage caused by aristolochic acid has dropped significantly, and no reports of direct kidney cancer have been received.

In the next step, the Food and Drug Administration will conduct special inspections of aristolochic acid-containing products on the market, and organize technical institutions and experts to conduct risk assessments of aristolochic acid-containing medicinal materials and proprietary Chinese medicines. At the same time, the Food and Drug Administration reminds patients that drugs should be used strictly in accordance with doctor's prescriptions and instructions, and be aware of the risks of nephrotoxicity and carcinogenesis of drugs containing Aristolochia. No medicine should be taken in large doses or for a long time.