A “Black Box Warning” On Prescription Acetaminophen


This file photo made June 30, 2009, shows Tylenol Extra Strength in Palo Alto, Calif. (AP Photo/Paul Sakuma, File)

Acetaminophen Kills 150 Americans a Year: Report

And the toll doesn’t have to be that high, investigative report concludes

By Kevin Spak, Newser Staff

The FDA has been dragging its feet when it comes to regulating acetaminophen—the active ingredient in Tylenol and many other drugs—or at least implementing safety precautions, and Americans have been dying as it does so, a new Pro Publica/This American Life investigation concludes. Over the past decade more than 1,500 Americans have died of acetaminophen overdose, or about 150 a year. But the FDA has repeatedly put off measures that might curb the problem, even though its own advisory committees have been urging increased safety measures since 1977. It blew its most recent deadline for new rules just last month. Too much acetaminophen can seriously damage the liver, so it’s dangerous in too-large doses or when combined with alcohol.

The margin between a safe acetaminophen dose and a dangerous one is unusually small, which has led several other countries to put limits on sales. But McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, has long battled against such measures in the US. To its credit, McNeil has also funded development on an antidote to acetaminophen poisoning, among other safety measures. At one point it tried and failed to create a safer acetaminophen alternative, but kept that research secret. The FDA, meanwhile, has placed a “black box warning” on prescription acetaminophen, warning that overdoses can cause death, but not on the over-the-counter version. “It’s among our top priorities,” one FDA expert says. “It just takes time.”

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