Two advisory committees urged the federal Food and Drug Administration on Wednesday to order warning labels for aspirin and ibuprofen, telling heavy drinkers that they risk stomach bleeding if they take the non-prescription pain relievers.
The vote was the latest development affecting a squabble among manufacturers of various painkillers. Each claims the others are more potentially harmful to people who use and abuse alcohol.
Doctors say they do not know how much alcohol has to be consumed before taking any of the drugs becomes dangerous.
“But in general, we’re talking about heavy drinkers,” said Dr. Martin Black, a Temple University professor who argued against the labels at a hearing Wednesday.
None of the health problems discussed, such as stomach bleeding, are common, said Dr. George Ehrlich, a member of the FDA’s Arthritis Advisory Committee.
“All of these side effects are relatively uncommon. Otherwise they wouldn’t be on the market,” he said.
The Aspirin Foundation of America Inc. said it was disappointed with the recommendation, which was issued by the arthritis panel and the FDA’s Over-the-Counter Drugs Advisory Committee.
“Aspirin is one of the safest, most commonly taken drugs (and) has been used by millions of people for over 100 years,” said Dr. Thomas E. Bryant, president of the group.
Doctors have been citing conflicting studies to the panel members since June, when the Over-the-Counter Drugs Advisory Committee recommended labeling the painkiller acetominophen to warn heavy drinkers of the risk of serious liver damage if they take too much of the drug.
But the panel asked the FDA to delay putting the warning on acetominophen--contained in Tylenol and other painkillers--until it also considered warnings about the hazards of mixing alcohol with aspirin, ibuprofen and other drugs.