FDA Issuing New Warnings About Acetaminophen

health, FDA, acetaminophen, tylenol

The Food and Drug Administration (FDA) is issuing new warnings to physicians about acetaminophen causing liver damage, and recommending they stop prescribing certain combinations of medicine which contain over 325 milligrams of the drug in each pill. This is due to long held apprehensions that high dosages cause liver damage. The FDA wants doctors to limit prescriptions of the product to no more than the milligram amount mentioned. The drug has been used for many years in order to lessen fevers and help people get rid of pains and aches. However, with extensive use comes the high risk of harming the liver.

There is no existing information which shows that taking more than 325 mg of acetaminophen per dose gives any added benefits that are able to outweigh the additional dangers that come with possible severe liver injury. Any unintentional acetaminophen overdose could cause the liver to fail, the person needing an emergency liver transplant or even death. The trouble comes in where there are numerous consumers who are unaware that countless products have acetaminophen as an ingredient, therefore making it very easy to accidentally ingest too much.

The National Institutes of Health explained that acetaminophen overdose has become one of the most common poisoning seen around the world.

The request of doctors came on Tuesday and is just one of a succession of actions that the FDA is taking in order to begin limiting any high-dosage use of the popular painkiller. The administration had already asked acetaminophen drug companies to stop making any combination of prescription drugs that have the higher doses. So far, over half of the drug manufacturers have agreed.

These medications most typically mix acetaminophen with some sort of opioid painkillers, such as codeine or hydrocodone. Some of the brand names it is found under are Percocet, Vicodine and Tylenol with Codeine. These are usually prescribed after specific types of injuries, dental procedures and surgeries. The organization states that over-the-counter Tylenol does not typically fall under this warning but agencies should work more closely to address acetaminophen health concerns that are present in over the counter drugs.

The FDA has also announced it is going to also refuse any type of approval for medications which contain over 325 mg of acetaminophen. There are also new plans in the works over different regulatory action on acetaminophen which is sold over-the-counter, but no details have been released yet.

These non-prescription painkillers, like Extra Strength Tylenol, have 500 mg of acetaminophen in every single pill. Tylenol’s creator Johnson & Johnson just announced it was going to put warning labels on to the caps of medicine bottle caps tin order to remind customers to read the medication label for safety and dosage instructions.

It is believed that acetaminophen overdoses send nearly 56,100 people to emergency rooms and kill over 500 individuals every single year, stated the FDA. Acetaminophen is a major cause of acute liver failure. Some of the reported overdoses were from people that had taken more than just a prescription dose. They were also found to be under the influence of alcohol or some other type of drug or drugs.

The Food and Drug Administration wants doctors to stop prescribing the certain combinations of medicine which contain over 325 milligrams of acetaminophen in each of the pills. Hopefully this will start to bring some help to in reducing the amount of liver damage cases reported.

By Kimberly Ruble



USA Today

Science World Report

3 Responses to "FDA Issuing New Warnings About Acetaminophen"

  1. autismepi   January 15, 2014 at 8:07 pm

    Liver damage is not the only thing to be concerned about. A well done, yet largely ignored study showed that children exposed to prolonged prenatal use of acetaminophen had substantially adverse developmental outcomes at 3 years of age (autism phenotypes).


  2. Bob Carson   January 15, 2014 at 4:29 pm

    Naproxen and Ibuprofen have their risks also. Is acetaminophen a preferred alternative to these for those who have constant pain but choose not to go the prescription pain killer route?

  3. Bob Carson   January 15, 2014 at 4:24 pm

    This information is not complete nor clear. For years, we were told the maximum safe dosage of acetaminophen was 4,000 mg per day (8 extra strength 500 mg tablets, not more than two tablets per 6 hour period). Not too long ago, it was recommended that this be reduced to 6,000 mg per day. Is it safe to take two extra strength every eight hours? Is there a limit on how long the recommended dosage can be taken?

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