The U.S. Food & Drug Administration (FDA) is considering whether to change the way acetaminophen (Tylenol) is marketed and consumed because too much of the drug may cause hepatoxicity. It's a word that has been used a great deal lately, but what is hepatoxicity and what are its symptoms?
Hepatoxicity defined
Simply stated, hepatoxicity is defined as hepatic (having to do with the liver) toxicity. It implies damage or injury to the liver which is caused by a drug, chemical or other agent. The liver plays a central role in transforming and clearing chemicals; however, it is susceptible to toxicity. Mild damage to the liver may cause a few symptoms (discussed below), whereas severe damage can result in liver failure or even death.
While acetaminophen (most commonly known as Tylenol) can be tolerated in small dosages, studies show that an overdose can be very painful, lead to hepatoxicity and is the most common cause of drug induced liver disease and acute liver failure in the world.
Symptoms of hepatoxicity
Although symptoms of hepatoxicity may vary, studies show that the following 15 symptoms are generally the most common:
- Abdominal pain
- Abnormal liver function test results
- Diarrhea
- Enlarged liver
- Jaundice
- Loss of appetite
- Nausea
- Prolonged bleeding time
- Swelling in feet
- Tiredness
- Vomiting
- Weakness
- Weight increase due to water retention
- Yellow eyes
- Yellow skin
FDA considering drastic changes to acetaminophen usage
In late June of 2009, an FDA panel met for a two day hearing in Washington DC on acetaminophen marketing and usage. The panel recommended making the following changes:
- Changing the 1,000-mg over-the-counter dose to a prescription-only status.
- Lowering the maximum daily dosage for acetaminophen from the current 4,000 mg to 2,600 mg and Lowering the single adult dosage from 1,000 mg to 650 mg.
- Making the 500 mg acetaminophen pill available by prescription only.
- Placing a black box warning on prescription medications that combine acetaminophen with another drug.
- Taking opioid drugs that contain acetaminophen, such as Vicodin and Percocet, off the market.
The FDA will decide whether or not to implement these changes within the next few months. However, products liability attorneys say that lawsuits against acetaminophen manufacturers have already begun.
