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 Aleve.
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 relief."
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 reporters.