It is reported that in the past two years, ProPublica, a non-profit survey news agency, has read tens of thousands of pages of documents and interviewed hundreds of people including US Food and Drug Administration officials, pharmaceutical company representatives, and victims. For the public to raise the risk alert: An antipyretic analgesic containing acetaminophen, careless consumption of a little can lead to liver failure and even death.
To sum up, the conclusions of the survey conducted by ProPublica, a well-known non-profit news agency in the United States, are as follows:
1. According to the FDA report, compared with other antipyretic analgesics, the "safe boundary" of acetaminophen is narrow, that is, if it is taken slightly above the prescribed maximum dose, serious injury can be caused. The FDA pointed out that this is a "serious public safety problem." At present, the FDA stipulated that the maximum dose of acetaminophen intake is 4 g/day. If each tablet containing Tylenol contains 500 mg of acetaminophen, it should not be taken more than 8 tablets per day; the total daily dose is 10 tablets. Liver injury or death, if it is a one-time oral, without eight tablets can be lethal.
2. McNeil, the manufacturer of the FDA and Tylenol, knew the risk of paracetamol poisoning in the late 1960s. Until 2011, the FDA still struggled with the problem of "accurate calculation of acetaminophen poisoning dose"; in the same year, the new regulations for each tablet contained no more than 325 mg of acetaminophen (effective from January 2014).
3. Over the past 30 years, the FDA has delayed or failed to adopt relevant regulatory measures to reduce the fatality rate of acetaminophen. As early as 1977, an FDA-affiliated expert committee made an urgent recommendation: "Must specify on the drug label that acetaminophen may cause severe liver damage." The FDA had a debate for 32 years until 2009 when the drug label was Have this annotation. The FDA's comprehensive safety review that began 36 years ago has not yet been completed.
4. McNeil has taken some measures to protect consumers. The most famous is to invest in research and development of detoxification after acetaminophen poisoning, which has saved many lives. However, over the past 30 years, it has frequently opposed safety warnings that indicate side effects of drugs on medicine boxes and opposes the introduction of measures to protect people taking medicines.
McNeil insisted that it strictly abide by FDA regulations. From beginning to end, it claimed its safety when it marketed Tylenol. However, in order to avoid possible lawsuits and huge compensation, advertisements almost never appear to be "safe." Its classic slogans include: Tylenol is "the most used analgesic in hospitals"; "the doctor recommended the most brands"; "like the hospital, I believe Tylenol"; "Pediatrician recommended" and so on.
Drug dealers argue or understand why the FDA, which is supposed to guard the public interest, does not move. Dr. Sandy, the FDA's chief medical scientist, said in a recent interview that, among over-the-counter drugs, the safety supervision of acetaminophen has been listed as the “primary issue†and “this is only a matter of timeâ€.
However, it has been 36 years since the FDA knew that the risk of paracetamol poisoning was not long enough.
The survey's inspiration and reference to China's ProPublica, a US news research agency, investigated that the U.S. Food and Drug Administration (FDA), the U.S. Congress (Legislative Authority) and pharmacists have taken some measures to allow the use of acetaminophen. Drugs are safer.
Some of the safety measures it recommends are also inspiration and reference for China.
1. Decrease the maximum daily intake of acetaminophen from 4 g to 3 g (FDA and pharmacists can do);
2. Make a safety manual for acetaminophen specifically for children (FDA can do);
3. Restrict the purchase of acetaminophen (the FDA and Congress can do);
4. Limit the concentration of acetaminophen in a single drug (FDA and Pharmacopoeia can do);
5. The advertising content of acetaminophen must explicitly warn that "overdose can cause a little bit of liver failure and death" (pharmaceutical companies voluntarily or Congress legislation);
6. A unified icon for acetaminophen drugs, to avoid consumers mixing two such drugs poisoning (FDA and drug dealers can do);
7. The kit or vial awoke to indicate that "overdose can be fatal" (FDA and drug dealers can do this).
Nanjing Survey:
Most cold medicines do not indicate excessive levels of cold medicine on the Nanjing market. Yesterday, at Jinling Grand Pharmacy in Xinjiekou, the reporter stated that he needed to buy cold medicine. The store's Purchasing Purchasing Officer briefly asked about the symptoms of the flu and took out a box of branded cold pills from the drug counter. He said that it was a proprietary Chinese medicine that did not require a prescription and that it worked well. In the kit and the inside instructions, the reporter did not find a warning about the excess of acetaminophen. For usage, the Purchasing Guide said that three times a day, 4-8 can be.
In the instructions on the back of a box of Ganmao Ling capsules, the reporter saw that the ingredients clearly contained in the medicines contained 100 mg of acetaminophen, 2 mg of caffeine, and 2 mg of chlorpheniramine maleate. However, it simply stated that the dosage was two pills at a time and three times a day. It did not indicate whether or not the amount of children needed should be taken into account. "According to the above instructions, it's fine, no problem." The shopping guide just glanced at the medicine box at random, and did not ask the reporter's weight, and did not make specific reminders on the amount of drug use. "This and the same In medicine, that effect is better."
The reporter then saw that most of the prescription drugs for colds did not indicate excessive risk in another supermarket pharmacy, and only a few drugs were marked with a weight and dose conversion table. The staff of the pharmacy only indicated that they would read the “research†manual.
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