FDA Warns High Doses of Acetaminophen Can Lead To Liver Damage

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The FDA has just issued a statement urging medical doctors not to prescribe acetaminophen in doses greater than 325 mg. Liver injury has been a known risk of the drug for many years, with even low doses posing serious dangers in excess of the prolonged-term. One more issue, however, is substantial doses in the quick-term, which can be a distinct danger if men and women aren’t mindful that they’re taking numerous acetaminophen-containing medicines. For illustration, prescription drugs, like oxycodone (Percocet), codeine, and hydrocodone (Vicodin) all include acetaminophen, so folks might unwittingly give themselves a double-dose by popping a Tylenol while already one of these prescription meds. And this, the FDA says, has to quit.

“Many customers are usually unaware that many goods (each prescription and OTC) contain acetaminophen, creating it straightforward to accidentally take also much,” mentioned the FDA.

Acetaminophen poisoning is one of the most widespread types of drug toxicity in the world, according to the NIH.

Acetaminophen can cause liver injury since the organ processes any compound that passes by means of. In the case of acetaminophen, a byproduct of its breakdown, NAPQI, can create up and significantly damage the liver’s own cells.

Because of these hazards, which far overshadow the positive aspects of the drug, the FDA says it is time to limit the dosage in prescriptions. “There are no available data to present that taking much more than 325 mg of acetaminophen per dosage unit supplies further advantage that outweighs the additional dangers for liver injury.”

In accordance to the FDA, folks at risk of liver damage consist of people who:

• “took much more than the prescribed dose of an acetaminophen-containing product in a 24-hour period”


•  “took a lot more than one acetaminophen-containing item at the identical time”


• “drank alcohol even though taking acetaminophen products.”

The early symptoms of liver damage are typically vague and include loss of appetite, nausea, and vomiting, and can initially mistaken for other ailments, like the flu. More severe signs and symptoms incorporate stomach discomfort, convulsions, diarrhea, irritability, jaundice, and coma. “Liver harm can produce into liver failure or death above a number of days,” says the FDA.

The suggested optimum everyday limit is 4,000 mg, which is the sum in just four Additional Strength Tylenol. Over seven,000 mg/day is sufficient to result in serious overdose, according to the NIH.

To decrease the threat of liver injury, the FDA advises individuals to:

• Usually comply with dosing instructions and by no means get much more than indicated, since “even a modest sum far more than directed can lead to liver damage.”


• Don’t get acetaminophen for longer than directed.


• Don’t get a lot more than one acetaminophen-containing medication at a time.

For example, “your danger of liver harm goes up if you consider a medicine that contains acetaminophen to treat a headache, and while that medication is still operating in your physique, you take yet another medicine that includes acetaminophen to treat a cold,” according to the FDA.

The FDA will handle over-the-counter (OTC) acetaminophen in a separate statement. Once more, because cold and flu prescription drugs frequently have acetaminophen, it is exceptionally essential to examine the ingredients in any OTC medicine you consider, so that you really do not unwittingly double up. And often keep away from alcohol whilst you’re taking items containing acetaminophen, considering that the mixture of alcohol and acetaminophen can place your liver at especially substantial danger.

For much more information, please see the FDA’s web site on acetaminophen toxicity.

FDA Warns High Doses of Acetaminophen Can Lead To Liver Damage