The Food and Drug Administration announced Friday it intends to require warning labels on all over-the-counter pain relievers - including aspirin - advising consumers of them of potential health problems if they also consume three or more alcoholic drinks a day.
“Consumption of excessive alcohol while taking pain relievers can be dangerous to your health,” Deputy FDA Commissioner Michael Friedman said in a statement.
For instance, acetaminophen - most commonly known by the trade name Tylenol - can cause liver damage if taken by heavy drinkers, agency officials said, while aspirin, drugs such as Advil containing ibuprofen and other analgesics can result in stomach bleeding.
Despite experts’ repeated warnings that all drug products pose some side effects, consumers generally have regarded over-the-counter pain-killers as benign. But disturbing reports in recent years have linked the use of certain of these products to a variety of problems when used for long periods by themselves or combined with heavy alcohol use.
Some manufacturers voluntarily have placed alcohol warnings on their products, but the FDA’s proposed label would require consistent and universal wording.
The label for acetaminophen products would say: “Alcohol warning: If you drink three or more alcoholic beverages daily, you should ask your doctor whether you should take (product name) or other pain relievers. (Product name) may increase your risk of liver damage.”
For aspirin and other pain relievers (known as analgesics) the FDA proposes the same wording, except substitutes “stomach bleeding” for “liver damage.”
A spokesman for the Non-Prescription Drug Manufacturers Association, the trade group for over-the-counter drug-makers, said his group had no immediate comment.
But the Aspirin Foundation of America issued a statement saying it does not believe “warnings for heavy drinkers or alcoholics are warranted for aspirin products.” The foundation plans “to take part fully in the rule-making process” to persuade the FDA of its position.
Ron Schmid, a spokesman for one of the companies that comprise Johnson & Johnson, maker of Tylenol, said the company had “voluntarily put an alcohol warning on the entire acetaminophen product line. …We felt right from the start that all manufacturers should have an alcohol warning.”