A Food & Drug Administration (FDA) Advisory Panel is recommending that the maximum daily dosage of acetaminophen, most commonly known as Johnson & Johnson's Tylenol, should be decreased by 35% to avoid liver damage.
Acetaminophen Overdose Injuries
After a two day meeting, an FDA Advisory Panel voted 21 to 16 to lower the daily doses of acetaminophen by 35% – from 4,000 milligrams to 2,600 milligrams. The Panel said that its research showed a strong link between acetaminophen and liver damage. In fact, it cited research which showed that there were 458 deaths, 26,000 hospitalizations and 56,000 emergency room visits due to acetaminophen overdoses from 1990 to 1998.
The Panel believes that one of the likely reasons for those high numbers is that consumers don't realize the extent to which acetaminophen can damage the liver. So many other over the counter (OTC) drugs such as cold remedies also generally contain acetaminophen, so consumers may be overdosing on acetaminophen without knowing it.
Banning Percocet & Vicoden?
In addition to its recommendation to decrease the daily maximum amounts of acetaminophen, the FDA Panel also suggested that Abbott Laboratories' Vicodin and Chadds Ford's Percocet, both of which contain acetaminophen, should be taken off the market as many consumers generally use acetaminophen and Vicodin or Percocet simultaneously. The FDA is not required to follow the Panel's advice; however, it usually does. If that happens, these manufacturers will likely try to work with the FDA to find a way to keep their drugs on the market.
Highlight of proposed changes
The Panel recommended the following:
Placing a black box warning on OTC medications containing acetaminophen
Reducing the single maximum adult dose of acetaminophen to 650 mg, instead of the current 1,000 mg
Lowering the daily maximum dosage of acetaminophen from 4,000 mg to 2,600 mg
Eliminating Vicodin and Percocet
To view a CBS news video on the issue, please click here.
Tylenol & Suicide
The link between Tylenol overdose and suicide has also become part of the acetaminophen controversy. Contrary to what many consumers believe, suicidal persons often use Tylenol as a way to end their lives. However, Tylenol toxicity generally takes several days and the suicidal consumer often changes his or her mind over that time period – not realizing that the wheels are still in motion. Product liability lawyers say that Johnson & Johnson has long understood this, but has not done anything to warn consumers.
If you've been injured due to Tylenol use, contact an experienced Tylenol attorney to discuss your situation and evaluate your options. You may be entitled to compensation.
