FDA Mulls Acetaminophen Liver Damage Warnings

The Food and Drug Administration is considering whether to order stronger warnings be added to the packaging of Tylenol and other brands of pain-killing acetaminophen products to caution users about the increased risk of liver injury.

This week, an FDA report recommended tougher warnings and limits on doses of the popular types of prescription and over-the-counter pain killers, which millions of Americans take for mild to moderate headaches, muscle pains, and other ailments.

However, too much acetaminophen can cause a condition called hepatotoxicity, which results in severe liver injury, the FDA said.

Acetaminophen toxicity is a risk in part because the drug is present in many over-the-counter combination drugs, which increases the chances of overdoses in consumers who take the combination drugs not knowing the products contain acetaminophen, the FDA said.

An FDA advisory panel of experts is scheduled to meet in June to discuss the FDA report findings, officials said. The panel could recommend that the FDA order stronger warning labels about the risks of liver damage and other side effects and other restrictions on the use of acetaminophen products.

The newly released report also recommends that adults take no more than 3,250 milligrams of acetaminophen daily and that liquid forms of the drug for children be limited.

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