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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Acetaminophen Products Can Cause Liver Injury

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This year the U.S. Food and Drug Administration (FDA) will begin recommending health care professionals discontinue the prescription of drug products containing more than 325 milligrams of acetaminophen per tablet, capsule, or other dosage unit.

The recommendation, which comes as a follow up to an FDA request of 2011, asking manufacturers to limit the amount of acetaminophen to no more than 325 milligrams in each capsule by January 14, 2014, is an attempt to curve dangerous levels of the drug in combination medications.

Acetaminophen, an active ingredient in medications such as Tylenol, assists in pain relief, but can lead to liver injury if taken in more than 325 milligram doses.

With no available data to support any benefit of taking more than 325 milligrams of the drug, the risks well outweigh the benefit.

Those that continually take dosages higher than 325 milligrams open themselves up to health risks such as severe liver injury, liver failure, transplant, and even death.

Acetaminophen caused severe liver injury in patients who:

  • Took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
  • Took more than one acetaminophen-containing product at the same time; or
  • Drank alcohol while taking acetaminophen products.

Widely used over the counter pain reliever, is often combined with other ingredients, and is sometimes disguised as cold or cough medication, confusing consumers and leading to potential over dosage.

The FDA intends to institute proceedings that would withdraw approval of prescription combination drug products which contain more than 325 milligrams that are currently on the market today.

If you are currently taking medication which contains acetaminophen it is recommended that you consult with your medical care provider immediately to reduce the dosage as appropriate. Although pharmacists have been warned of the milligram limit, many medications continue to be prepared with a dose exceeding the recommended 325 milligrams.

Until strict regulations are passed, it is up to the users to be proactive, and ensure their medication is not only effective, but safe.