New FDA regulations restrict doctors from using cold medicines containing paracetamol

2014-01-20 source: Recently, the first financial daily reported a wave of cold drugs After new Kangtaike was exposed as a raw material for drug production, the U.S Food and Drug Administration (FDA) recently issued a notice to restrict the use of cold drugs containing paracetamol by doctors Acetaminophen, as one of the most commonly used non anti-inflammatory, antipyretic and analgesic drugs, is the main component of a variety of cold antipyretic and analgesic drugs At present, it is contained in common cold drugs such as Tylenol, baifuning, and bilitong According to FDA statistics, acetaminophen overdose was the main cause of liver failure from 1998 to 2003 The FDA warns that excessive use of acetaminophen can lead to a risk of serious liver damage, which can lead to liver failure or even death The FDA said it would urge doctors to avoid prescribing drugs containing more than 325 mg / tablet (or capsule) paracetamol to reduce the risk of liver damage to patients "Paracetamol is almost contained in cold medicines in China, and it is also added in some Chinese patent medicines, such as Sanjiu Ganmaoling capsule, which looks like a Chinese patent medicine, but each capsule also contains 100mg paracetamol." Yesterday, Yu Pei, Dean of the Department of pharmacy, School of pharmacy, Jinan University, told the first financial daily It can be seen from the product manual that each tablet of Tylenol under Johnson & Johnson pharmaceutical contains 325 mg paracetamol, while the content of paracetamol in each tablet of perphenazine under Squibb is as high as 500 mg Yu Pei told reporters that although the maximum dose of paracetamol taken by adults within 24 hours a day is 4 grams, there are still many problems in real life "There has always been a concept of 325 mg safe dose in the academic world The FDA standard must be based on a large number of clinical test data." Yu Pei said In fact, in January 2011, the FDA asked drug manufacturers to limit the content of paracetamol to no more than 325 mg / tablet At present, more than half of the manufacturers have voluntarily complied with this requirement, but there are still more than 325 mg of drugs "Metabolism in the human body will produce an intermediate If it can't be completely metabolized by the human body, it will cause serious damage to the liver and kidney, and even cause death," Yu said If the patient's endocrine or metabolism problems, or drinking after taking the drug added to the substance, then the toxicity to the human body will be greater " "But the problem is that the content of a single product is not too large first Because many patients don't understand this, they often take Tylenol, phenformin and other proprietary Chinese medicine at the same time The combination of drugs is very easy to lead to excessive intake, and the risk will be accumulated over time." Yu Pei said Gao Huijun, deputy director of Shanghai food and drug safety research center, told reporters that there are no relevant regulations in China at present China and the United States have different drug use habits The United States draws this safety warning line based on the data of adverse reactions it monitors However, China needs to make an assessment based on its own monitoring data "At the beginning, there was a basis for those large-scale dosage forms to pass the examination and approval of the drug regulatory bureau, but now patients often recognize the brand when they choose cold medicine, and they don't think about the internal differences of different products Next, relevant departments should sort out the dosage of paracetamol in different products, require enterprises to set up warning signs to distinguish, and give guidance to products with different contents " Gao Huijun said "Some products add large doses of acetaminophen in order to enhance the efficacy, but as antipyretic and analgesic drugs, low content can also produce effects, no more than 200 mg / tablet or even less." Yu Pei thinks Yesterday, the reporter interviewed part of the production and sales of cold medicine (market area) enterprises, are told that this is still unknown