By Will Glover
Staff Writer
The next time you have a hangover and reach for Tylenol to alleviate your headache, you might want to think again.
In 1995, the FDA Advisory Committees recommended that all over-the-counter pain relievers such as Tylenol carry an alcohol warning. The warning, which appears on the label of all adult Tylenol products, reads as follows: "If you generally consume three or more alcohol-containing drinks per day, you should consult your physician for advice on when and how you should take Tylenol and other pain relievers."
Tylenol was the first over-the-counter pain reliever to add the alcohol warning label, in part because of a lawsuit brought again McNeil Consumer Products by 39-year-old Antonio Benedi of Fairfax, Virginia. Benedi claimed that his liver was destroyed by a toxic reaction in his body caused by taking Extra Strength Tylenol and drinking wine every night. He later had to undergo a kidney transplant.
A jury agreed with Benedi and awarded him $8.8 million. The judgment was upheld in a federal appeals court. The ruling prompted an FDA review of over-the-counter pain relievers and their reaction with alcohol.
Acetaminophen, the active ingredient in Tylenol, has been named in several studies in the past 10 years as the cause of sudden liver failure in rare instances. Many of the cases involved heavy drinkers.
Dr. Eric Dahl, head physician of Ole Miss's Student Health Center, says that Tylenol as well as other pain relievers can be harmful.
"The problem is synergism," Dahl said. "Synergism is where the force of two is greater than their sum. Both of these drugs (alcohol and Tylenol) are metabolized in the liver."
When a person consumes too much of the drugs together, they can combine to harm the liver. Dahl says that how much a person can handle of the two drugs varies. "It depends on how fast your body metabolizes what's in there. The body can safely handle a drink per hour. It likes to have less than two drinks a day on average."
"Most people, when they reach a certain blood-alcohol level, pass out, so the body has time to metabolize the alcohol," Dahl said. "If you clog the liver with Tylenol or Advil, both act as a poison to damage the liver."
Statistics show that close to only one in 1,000 to 100,000 people have side effects after taking over-the-counter pain relievers.
"The vast majority of people get away with (mixing pain relievers and alcohol)," Dahl said. "You can't predict who will have what response."
Dahl says that after consuming alcohol, as a general rule, one should avoid taking Tylenol or an ibuprofen such as Advil for six hours, depending on whether the alcohol was taken on an empty stomach and the amount of alcohol consumed.
At the FDA panel hearings on acetaminophen, an expert testifying for the makers of Advil said that individuals who drink more than two alcoholic beverages a day should not take more than two grams of acetaminophen a day. The makers of Tylenol pointed out that ibuprofen can cause gastrointestinal bleeding in heavy drinkers.
"Both (Advil and Tylenol) are wonderful drugs with a safety profile that is terrific," Dr. David Katzka, a gastroenterologist at the University of Pennsylvania School of Medicine said in a 1996 New York Times article. "It is only a very small minority of people who take the drugs and have serious side effects. Gastrointestinal bleeding associated with ibuprofen is a more common problem, but the severe liver toxicity you get in rare cases with acetaminophen is more serious."
Also toxic is switching from acetaminophen to ibuprofen, the New York Times said.
Currently, Tylenol (acetaminophen), BC (aspirin), Orudis KT (ketoprofen), and Aleve (naproxen sodium) are the only over-the-counter pain relievers that carry the alcohol warning label. The makers of Advil have fought the FDA ruling. According to a statement released by the company, the company has not put an alcohol warning on Advil because "scientific data does not support such a warning."
"Combining drugs, especially alcohol, is very dangerous if you don't have a physician's guidance," Dahl said. "You're running the risk of serious injury or death."