Food will evaluate drug safety administration “aristolochic acid” security

recently, aristolochic acid topic correlation with liver cancer causing concern. The state food and drug administration spokesman said, according to the epidemiological big sample, data analysis, liver cancer patients in our country is mainly caused by the hepatitis b virus infection. Whether to have direct relationship with aristolochic acid, there is no strong data support directly. DetailPic

data diagram (for figure/visual China)

food safety administration of drug safety in response to recent aristolochic acid a dispute, will organize technical institutions and experts to conduct the risk assessment of herbs containing aristolochic acid

recently, the Beijing news dispatch (reporter li dandan) of aristolochic acid topic correlation with liver cancer causing concern. The state food and drug administration spokesman said, according to the epidemiological big sample, data analysis, liver cancer patients in our country is mainly caused by the hepatitis b virus infection. Whether to have direct relationship with aristolochic acid, there is no strong data support directly.

aristolochic acid is who, as a type I carcinogen

on October 18, the United States of academic papers published in the journal science translational medicine cause the attention of the public for aristolochic acid.

state food drug safety administration spokesman said, we encourage scientific research and the discussion. At present, according to the epidemiological big sample, data analysis, liver cancer patients in our country is mainly caused by the hepatitis b virus infection. Whether to have direct relationship with aristolochic acid, there is no powerful data support directly.

but the spokesman said, has obvious renal toxicity of aristolochic acid, can cause renal tubular function is impaired, even cause the risk of kidney cancer. In 2002, the world health organization (WHO), the international agency for research on cancer (iarc) has classified aristolochic acid a potential carcinogens, 2012 in its list of type I carcinogen.

in our country has to contain aristolochic acid drugs take control measures

according to introducing, at present not all aristolochiaceae plants containing aristolochic acid. In recent years, countries such as America, Britain, Germany and China Taiwan region are on aristolochic acid and disable restrictions.

since 2003 in China also have some herbs containing aristolochic acid and Chinese patent medicine has adopted a series of risk control measures, including banning the use of high content of aristolochic acid in close also, wide acutum and radix aristolochiae; Adjust the medicine use parts; Clear warnings of oral proprietary Chinese medicine containing aristolochia genus medicine varieties in strict accordance with the prescription management; Develop the toxic herbs and other security issues varieties of traditional Chinese medicine treatment principles.

food drug safety administration spokeswoman said the measures after the aristolochic acid renal damage number of cases have fallen sharply, not yet received directly cause kidney cancer report.

in fact, the medicine containing aristolochic acid used in China for thousands of years of history. At present, contains the Chinese pharmacopoeia, ministerial standard and local standards of aristolochiaceae medicinal herbs have 24 kinds, proprietary Chinese medicine oral preparations containing aristolochia genus medicinal materials have 47, feed, are available on drug safety administration website.

& other; We remind patients, the drug should be used strictly in accordance with the doctors’ prescriptions and the doctor’s advice, pay attention to kidney containing aristolochia genus drug toxicity, carcinogenicity risk, & throughout; Food, a spokesman for drug safety administration of any drug can large dose, take long time.

will be listed on the special inspection of products containing aristolochic acid to

it is understood that the food and drug regulator for listed products containing aristolochic acid to carry on the special inspection, to strengthen the examination, to crack down on illegal production, management behavior. Strengthen basic research foundation of the proprietary Chinese medicine, to carry out the related medicines and proprietary Chinese medicine using epidemiological investigation, targeted to national adverse drug reaction monitoring data in liver damage cases of system analysis, and organize technical institutions and experts of medicines and proprietary Chinese medicines containing aristolochic acid in risk assessment, the research take careful, restricted, risk control measures such as stopping.

food drug safety administration, said a spokesman for the food agency to strengthen supervision, supervision of production enterprise strictly implement the national drug standard, strict enforcement of asarum medicinal materials can only use the root and rhizome, banning the use of part as slices and traditional Chinese medicine preparations of raw materials on the ground.

in addition, all the medicine containing aristolochic acid as raw materials production enterprises, will be made for its products safety evaluation, the time limit for providing assessment conclusion, exceed the time limit has failed to provide the assessment conclusion, to stop the production, the cancellation of drug approval number; Assessment conclusion, risk control measures are put forward, after review by drug approval center, improve the instruction of benefit is greater than the risk, the risk is greater than the benefit give fall into disuse.

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