Common Pain Drugs to Get New Warnings
Acetaminophen, Aspirin, NSAIDs Face New FDA Alerts
Dec. 19, 2006 -- Over-the-counter pain relievers used by hundreds of
millions of Americans will carry stricter safety warnings under regulations
proposed Tuesday by the FDA.
Labels would warn of the potential for severe liver damage with the use of
acetaminophen, the pain reliever contained in Tylenol. Warnings would also go
on painkillers known as nonsteroidal anti-inflammatory drugs (NSAIDs),
including ibuprofen, aspirin, and naproxen, cautioning of a risk of
gastrointestinal bleeding with overuse. Brand names include Advil, Motrin, and
Many nonprescription drugs already carry similar warnings. But FDA officials
said they are seeking to make the alerts more visible and specific after
reports suggesting that injury related to common pain relievers -- while
uncommon -- is more prevalent than previously thought.
"We think that warning has to be more prominently displayed," said
Charles Ganley, MD, director of the FDA's office of nonprescription products.
"The consumers have to be more cognizant of what they're taking for pain
There are more than 20 different forms of NSAIDs, though not all are
available without a prescription. Still, together with acetaminophen, they
comprise hundreds of products.
New Labels Proposed
The agency said it intends to require acetaminophen manufacturers to display
the words "liver warning" in prominent type on packaging. Labels must
alert consumers that severe liver damage can result if they take more than the
recommended maximum daily dose, combine the pills with other drugs and those
that also contain acetaminophen, or drink moderate amounts of alcohol while
taking the drug.
NSAIDs would have to carry similarly prominent warnings saying the drugs can
lead to gastrointestinal bleeding in patients over 60, those with previous ulcersor
bleeding, those who take a blood thinner, those taking more than one product
containing an NSAID, and in patients already taking certain medications such as
a corticosteroid like prednisone.
The drugs would also continue to carry existing alerts about exceeding the
maximum daily dose, taking it for longer than directed, and mixing them with
alcohol, the agency said.
Ganley said the agency believes acetaminophen to be "quite safe" but
that risk of liver failure exists for the hundreds of millions
of Americans who take the drugs.
"Those rare circumstances are adding up to large numbers," he told