Acetaminophen, the active ingredient in Tylenol, is the number one cause of acute liver failure in the United States according to the FDA. Over 50,000 visits to emergency rooms, 23,000 hospitalizations and 450 deaths per year are directly related to acetaminophen.
Tylenol and similar generic brands of acetaminophen can cause elevated liver enzymes and liver damage at less than the recommended daily dose (8 extra strength tablets per day, or 4 grams). The FDA's Advisory Panel has recently recommended new guidelines reducing the maximum single dose from 500mg to 325 mg and a reduction in the current maximum daily dose (4 grams). [i] These recommendations are in an effort to curb the serious and often fatal injuries caused by acetaminophen.
Since the mid-1970's studies have shown that acetaminophen (the active ingredient in Tylenol and similar generic brands), when combined with regular alcohol use, can cause liver damage - even when taken at recommended dose levels. However, it was not until almost three decades later that labeling for acetaminophen products was changed to include such a warning.
Since the mid-1990's studies have shown that acetaminophen, when combined with fasting or not eating properly, can cause liver damage. Most often the "fasting" occurs in people who are suffering flu-like symptoms (nausea, vomiting, loss of appetite), or dental pain, who are taking acetaminophen within recommended dose amounts. These studies, like the current FDA recommendations, suggest a need to be more cautious when taking this "doctor recommended" over the counter pain reliever.
Acetaminophen when taken at "regular strength" levels (325mg tablets) provides the maximum effective pain relief offered by acetaminophen to over 98% of consumers. So, why make it in 500mg strength - adding to the potential for injury? Primarily, because anything labeled "extra strength" will sell better. Its pure marketing strategy - maybe less safe, but better sales.
Bottom Line: Acetaminophen products provide effective pain relief to millions of users every day. Most medical commentators agree that acetaminophen, when used at or below 2.6 grams per day (that is, taking no more than 8 regular strength tablets per day) and eating properly is safe. However, when exceeding therapeutic levels (recommended doses), Tylenol and acetaminophen containing products are one of the most dangerous over-the-counter products on the market.
[i]http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4429b1-01-FDA.pdf
