Common Pain Drugs to Get New Warnings
Acetaminophen, Aspirin, NSAIDs Face New FDA Alerts
Risk of Liver Failure
The FDA delved into the liver risks of acetaminophen in public hearings in
2002. At the time, manufacturers projected that over-the-counter use of the
drug could lead to at most 200 cases of acute liver failure per year.
McNeil Consumer Healthcare, which manufactures Tylenol and Motrin, a pain
reliever containing ibuprofen, said in a statement Tuesday it had already moved
to include many of the warnings proposed by the FDA.
The company "will continue to work with the FDA to ensure appropriate
information is provided to consumers," says the statement from the company,
which is owned by Johnson & Johnson. Johnson & Johnson is a WebMD
A study published in 2004 reported that half of all cases of acute liver
failure in the U.S. were attributable to acetaminophen poisoning. Scientists
still debate how many of those injuries stem from accidental poisonings during
regular use vs. suicide attempts.
The report's author, William M. Lee, MD, praised the FDA's move but said
"it's only the start" of what the agency should do.
U.S. vs. British Rules
The rules would force manufacturers to label combination products like
Nyquil or Tylenol PM with the word "acetaminophen." But many experts,
including Lee, lobbied the agency to replicate rules in the U.K. limiting the
drug to 16 or 24-tablet packs.
"In the U.S. you can get 500 or 1,000 in a mayonnaise jar. Five hundred
is enough to kill 40 people. In the U.K., they know it's a poison," said
Lee, a professor of internal medicine at the University of Texas Southwestern
Medical Center in Dallas.
Ganley said the agency has asked for public comment on whether it should
consider limiting package quantities.
Companies have three months to comment on the FDA's proposed regulations.
Ganley said final rules ordering the changes are unlikely to occur by the end
"We are asking that people voluntarily comply in the interim," he