Tylenol and Liver Safety: What the Acetaminophen Warning Label Means

December

30

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Tylenol is one of the most widely used painkillers, and its liver safety has been the subject of studies and of a newer warning label. The Journal of the American Medical Association published a study in which healthy adults took the maximum daily dosage of the drug for two weeks, and many of them showed raised liver enzymes, a sign of stress on the liver.

Tylenol contains a substance known as acetaminophen, which is responsible for the pain relief. The Food and Drug Administration (FDA) has warned that taking too much of this substance can seriously harm the liver.

Many Tylenol users are unaware of this risk and take the drug to gain quick relief from pain. Acetaminophen is considered safe when used as directed, but the margin between the maximum recommended dose and a harmful dose is relatively small, so exceeding the dose on the label can lead to liver damage and, in severe cases, liver failure.

When too much of the drug is taken, its metabolites can damage liver cells, and researchers attribute a large share of the cases of sudden liver failure to acetaminophen overdose.

Tylenol has been a household name in America for decades, with millions of Americans taking it regularly. The statistics show why caution matters: acetaminophen overdose leads to tens of thousands of emergency room visits and hospitalizations in the U.S. every year, and to several hundred fatalities.

This study, conducted by Dr. Kenneth Simpson of the University of Edinburgh (Scotland), revealed that a “staggered overdose”, i.e. taking slightly too much over a period of time, can be even more dangerous than a single large overdose.

McNeil Consumer Healthcare, the company that makes and distributes Tylenol, which has long been marketed as a safe painkiller, has faced pressure from more than 85 personal injury lawsuits filed over Tylenol.

The company introduced a new label on the cap which reads “Contains acetaminophen” and “Always read the label” on Extra Strength Tylenol, which contains more than 50% more acetaminophen in each tablet than the Regular Strength version.

The same change was planned for Regular Strength Tylenol in the following months.

Matthew Perrone of the Associated Press wrote that this new label brings to the attention of users that Tylenol does contain acetaminophen, which is one of the leading causes of sudden liver failure in the country, and that the label should help people who do not otherwise read the warnings in the fine print.

An FDA advisory panel has also discussed tighter limits on acetaminophen in combination products, such as cough and cold remedies. In 2009, the panel recommended removing prescription combination painkillers such as Vicodin and Percocet from the market because they contain acetaminophen. The FDA did not ban them, but it later limited the amount of acetaminophen allowed in each tablet of prescription combination products.

How to Use Acetaminophen Safely

  • Never take more than the dose stated on the label, and do not take it for longer than directed.
  • Check the labels of all your medicines. Many cold, flu and pain products also contain acetaminophen, and the doses add up.
  • Avoid alcohol while taking acetaminophen.
  • If you have liver problems, or if a doctor has prescribed this medication to you, follow your doctor’s instructions and ask before making any change.
  • If you think you have taken too much, call your doctor or a poison control center right away, even if you feel fine.

Via Mercury News | Insider | The Mercury News

This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always talk to your doctor about any health concern.