The Food and Drug Administration yesterday proposed mandatory labeling for over-the-counter painkillers aspirin, acetaminophen and ibuprofen.
The new warning labels would apply to drugs such as Johnson & Johnson’s Tylenol, which contains acetaminophen; Wyeth’s Advil, which contains ibuprofen; and Bayer, which is aspirin. The drugs are found in hundreds of other painkillers, and cold and flu medications.
More than 200 million Americans take acetaminophen alone, federal officials said.
The FDA said that although the products are safe in recommended doses, liver toxicity and stomach bleeding can occur in people with certain conditions. In a worst-case scenario, an overdose of acetaminophen can lead to acute liver failure.
“Consumers have to be more cognizant of what they are taking for pain,” said Dr. Charles Ganley, director of the FDA’s Office of Nonprescription Products.
Currently, the manufacturers can choose to label potential adverse side effects. The proposed rule, which will be issued next week, sets in motion the process to make the labels not only mandatory but also more prominent on products containing acetaminophen or non-steroidal drugs such as aspirin and ibuprofen.
The requirement probably will not go into effect until sometime in 2008, because of the length of finalizing the federal regulation. Dr. Ganley would not pin down an effective date for the new requirement but said his office would finish writing the final regulation by the end of next year.
The number of liver-damage cases or stomach ailments associated with the drugs is not known, but Dr. Ganley estimated that as many as 200 deaths occur annually as result of taking acetaminophen.
Because the drugs are found in hundreds of products, the risks are magnified. For aspirin and ibuprofen, there is a risk of gastrointestinal bleeding and kidney injury. Overdoses of acetaminophen can cause liver damage.
“Because of the high number of people taking the drugs, the rare circumstances add up and we need to emphasize it more to the public,” Dr. Ganley said. “There is some indication that for acetaminophen, liver problems may be increasing.”
The proposed warning labels for acetaminophen would highlight the potential for liver toxicity, particularly when using the drug in high doses and when taking it with alcohol. And for aspirin and ibuprofen, the new warning labels would make more prominent the risk of stomach bleeding that can occur in people older than 60 or who have an ulcer.
For aspirin and ibuprofen, federal officials want the warnings to be more visible on the product. “The warning that is on there now is not the warning that we wanted,” Dr. Ganley said.
The FDA is urging companies that manufacture and market the drugs to voluntarily comply with the new warning labels. The pending regulation is not expected to affect drug makers’ stock prices or revenue, according to drug-industry financial analysts.
“This probably will not impact Johnson & Johnson or Bayer directly,” said Les Funtleyder, a health care analyst at the financial firm Miller Tabak.
The process of a stricter warning label for the ubiquitous products began in 2002 when advisory panels began meeting. Two years later, FDA officials finished the proposed regulation, but it has been in the federal regulatory clearing process until now.
“We are forced to do this through the regulatory process, it is an extremely laborious process and intolerably too slow,” Dr. Ganley said.
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