Aristolochic acid carcinogenic? Authority gives the latest response!



Food and Drug Administration will further strengthen supervision, conduct special inspections on listed aristolochic acid-containing products, strengthen inspection and testing, and severely crack down on illegal production and business activities.

A spokesperson for the State Food and Drug Administration told the media a few days ago that there is no direct and powerful data to support the direct correlation between aristolochic acid and liver cancer, but aristolochic acid has obvious nephrotoxicity and can cause damage to renal tubular function., There is even a risk of causing kidney cancer.

In view of this, my country has adopted a series of risk control measures since 2003. The number of cases of aristolochic acid kidney damage has dropped significantly, and no reports of direct kidney 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.

China has earlier adjusted the parts of medicinal materials, changing the medicinal parts of Aristolochiaceae Asarum from whole grass to roots and rhizomes.

In addition, China has banned the use of Aristolochic acid high content of Aristolochic acid, Guangfangji and Radix Aristolochiae, at the same time, it is clear that the oral proprietary Chinese medicine varieties containing aristolochia are strictly controlled by prescription drugs.

Food and Drug Administration reminds patients that drugs should be used in strict accordance with doctor's prescriptions and orders, and pay attention to the renal toxicity and carcinogenicity risks of drugs containing aristolochia. Any drug should not 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 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, risk control measures shall be proposed. After review by the Drug Evaluation Center, the instructions shall be revised and improved for benefits greater than risks, and those risks greater than benefits shall be eliminated.

According to reports, the State Administration of Food and Drug Administration will further strengthen basic research on Chinese patent medicines, carry out epidemiological investigations on the use of related medicinal materials and Chinese patent medicines, and conduct targeted investigations on liver injury cases in the national adverse drug reaction monitoring data. Systematic analysis, and organize technical institutions and experts to conduct risk assessments of medicinal materials containing aristolochic acid and Chinese patent medicines, and study and adopt risk control measures such as caution, restriction, and discontinuation.

Earlier reported

Is aristolochic acid the culprit of the high incidence of liver cancer in Asia?

Over the past few days, a scientific paper on the possibility of aristolochic acid causing liver cancer has sparked a heated debate in China.

Where does the claim that aristolochic acid causes cancer come from? Is aristolochic acid the culprit of the high incidence of liver cancer in some parts of Asia?

Xinhua News Agency reporter interviewed the author of the paper and third-party experts, etc., and brought the investigation immediately.

The American Journal of Science Translational Medicine published a cover paper in mid-October, entitled "Liver Cancer in Taiwan and Wider Asia Widely Related to Aristolochic Acid and Its Derivatives". The researchers came from Singapore and Taiwan, China.

Journal Editor's profile titled "The Dark Side of an Herbal Medicine" recommended the study.

This paper found that 78% of 98 samples from Taiwan, China, had aristolochic acid-induced mutant molecular tags, or "fingerprints", through sequencing analysis of liver cancer samples ".

In addition, 19% of the 26 samples from Vietnam contained aristolochic acid "fingerprints", while 56% of the 9 samples from other Southeast Asian countries had aristolochic acid "fingerprints".

Based on the analysis of more than 1400 liver cancer samples worldwide, the researchers concluded that there is a "definitive association" between aristolochic acid and liver cancer ".

They pointed out that herbs containing aristolochic acid are widely used in Asia, especially in Taiwan, China, but they did not directly say that aristolochic acid is the cause of the high incidence of liver cancer in the region. The author of the paper

exclusively responded to the first author of the paper

and Huang Weitian of Duke-National University of Singapore Medical School said in an email to a reporter from Xinhua News Agency: "We think these findings are quite important, although we already know that aristolochic acid can cause kidney failure and upper urinary tract cancer and is a dangerous substance, but we had no idea that aristolochic acid exposure was so common in liver cancer."

Huang Weitian explained that for aristolochic acid "fingerprint", "all (other) known mutagens do not produce this label. We analyzed the genomes of liver cancer patients and found a large number of such mutations, some of which are located in genes that may cause cancer once mutated."

As to whether there is a causal relationship between aristolochic acid intake and liver cancer, Huang Weitian said that the problem can be divided into two parts:

, is aristolochic acid causing mutation?

2, what is the cancer risk of these mutations?

They are now "99% sure" that aristolochic acid causes mutations, and these mutations are more accurately cancer risk factors. How different levels of aristolochic acid exposure increase the risk of liver cancer needs further research.

Controversy of Aristolochic Acid

Aristolochic Acid is naturally found in aristolochia plants such as Aristolochia, Asarum, Aristolochiae, Guangfangji, Aristolochiae, Guisongfeng, Tianxianteng and Vermilion.

Related Chinese herbal medicines have been used to treat rheumatism, gout and other diseases, and are widely used in weight loss and menstrual symptoms.

Aristolochic acid has caused controversy many times in history. In the 1990 s, a Belgian study found that herbal diet pills containing aristolochic acid caused kidney damage in women.

In 2003, many Chinese media reported that aristolochic acid in Longdan Xiegan Pills caused kidney disease. That year, the State Food and Drug Administration of China canceled the medicinal standard for aristolochic acid.

The Singapore team that conducted this study reported in Science Translational Medicine in the United States in 2013 that aristolochic acid caused more gene mutations than other carcinogens such as tobacco and ultraviolet rays, confirming for the first time the correlation between aristolochic acid and liver cancer.

In addition to liver cancer and kidney disease, aristolochic acid has been thought to cause a variety of cancers such as urothelial cancer. In 2003, the International Center for Research on Cancer under the World Health Organization classified aristolochic acid as a "class I carcinogen".

Many European and American countries have banned the sale of

reporters inquired about the regulatory documents of various countries and found that the European Union and Singapore and other places began to ban the use of Chinese herbal medicines containing aristolochic acid from 2001 to 2005.

The US Food and Drug Administration also issued a warning letter in 2001, requiring consumers to stop using any plant products containing aristolochic acid.

Mark Radani, head of molecular diagnostic services at the Sloan-Kettering Cancer Institute in the United States, has been paying attention to aristolochic acid. "Although more questions need to be answered about this finding, such as how much aristolochic acid exposure is sufficient to cause liver cancer and what proportion of exposed patients will develop liver cancer, it is prudent to suspend the use of known aristolochic acid-containing traditional medicines now and to ensure that it does not contaminate traditional medicines through appropriate quality control procedures." "The risks (of aristolochic acid) are too high, and the benefits can only be said to be unclear at best."