Alcohol is a drug, and doctors remind us that mixing drugs can be dangerous.
But Tylenol? And a couple of glasses of wine?
Earlier this week a federal jury in Virginia awarded $8.8-million to a former White House aide who said his liver was destroyed by taking the pain-reliever Tylenol in combination with his regular consumption of wine with dinner.
The verdict will be appealed. Jeff Leebaw, a spokesman for Johnson & Johnson, the parent company to McNeil Consumer Products, which makes Tylenol, said "the injuries sustained by the plaintiff were caused by a pre-existing viral infection."
Nevertheless, the link between Tylenol and liver damage startled many social drinkers, who regard their imbibing as moderate and have even been reading lately about the beneficial effects of an occasional glass of wine.
Alcohol is so accepted socially, said Dr. Dan Buffington, a clinical pharmacologist at the University of South Florida, that people forget "it is a drug with very dramatic effects. Its risks are frequently underestimated."
In recent years, said Buffington, the U.S. Food and Drug Administration has begun to pay more attention to those risks.
"In every clinical trial we do here at USF (a clinical trial is a test of a drug seeking FDA approval) we now ask for information about alcohol use. We are seeing the FDA focus on alcohol more and more."
In June 1993, an FDA advisory committee recommended that the agency require a warning on pain killers containing acetaminophen (Tylenol) saying that heavy drinking while taking the drug could cause serious liver damage. Johnson & Johnson fought the warning, saying it would unnecessarily alarm consumers.
"We didn't think there was a need," said Leebaw. "The label already tells you how much medication to take. If you stay within recommended doses, social drinkers need not be concerned."
Lawyers for plaintiff Antonio Benedi said this week they found evidence in company records that 16 deaths and an unknown number of serious liver injuries have been caused by acetaminophen in combination with alcohol. Leebau said that he did not know if that figure was correct, but that the reaction between alcohol and acetaminophen is "very, very rare."
Problems "are a drop in the bucket compared to how often it (Tylenol) is used," he said. "And almost all of those cases involve chronic alcoholism and drug overdose.
"Look, too much alcohol is not good for the liver, an overdose of acetaminophen is not good for the liver, and too much of them together is certainly not good for the liver. But Tylenol has been around for 30 years and has an excellent safety record." About 55-million people in the United States take about 7-billion doses every year, he said.
FDA spokesman Don McLearn said the agency will make a decision by the end of the year. The agency, however, is expected to order alcohol warnings. In anticipation of that decision, drug companies are already including warnings with their product.
Procter & Gamble, manufacturers of Naproxen Sodium, marketed as Aleve, includes this statement on a leaflet inside the packaging: "Alcohol warning: 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 Aleve and other pain relievers."
The warning is the same on Tylenol Extended Relief, a product just introduced in July. By sometime next year, the warning will be on all types of Tylenol, said Leebaw. "It's going to take a while; there's already a lot of product out there."
The FDA's McLearn acknowledged the warning is vague about how much alcohol might cause a problem, but said the amount will vary with individuals. The warning, he said, will serve to alert people to risks they may have overlooked.
As for Johnson & Johnson's assertion that users need only take the recommended doses of pain relievers to avoid risk, USF's Buffington has a warning:
"It's not as simple as that," he said. "Anybody who chooses to consume alcohol, even in social patterns, should consider its use a risk factor. Alcohol has dramatic effects on the body, especially the liver."
Alcohol is a risk factor for a number of over-the-counter medications, Buffington said. If you have a concern, ask your doctor or pharmacist, he said.