Washington — Evidence that many Americans may poison their livers by unwittingly taking toxic doses of acetaminophen has the government considering if consumers need stiffer warnings about the popular over-the-counter painkiller.
It's not the first time acetaminophen, best known by the Tylenol brand, has drawn federal concern. There are warnings not to take it if you consume more than three alcoholic drinks, because the combination can poison your liver.
But the latest worry is about overdoses: taking too much for too long, or mixing the myriad acetaminophen-containing headache, cold/flu and other remedies, or just popping extra pills.
Because acetaminophen is nonprescription, people think "it must be safe and they take it like M&Ms," sighs Dr. William Lee of the University of Texas Southwestern Medical Center in Dallas.
Lee's data suggest acetaminophen overdoses could be a bigger cause of liver failure than some prescription drugs recently banned for liver poisoning, such as the diabetes medicine Rezulin.
He tracked more than 300 acute liver failure cases at 22 hospitals and linked 38 percent to acetaminophen, versus 18 percent of cases caused by other medications. In a second database tracking 307 adults suffering severe liver injury not full-fledged failure at six hospitals, Lee linked acetaminophen to 35 percent of cases.
Most were accidents and should have been preventable, Lee contends.
The findings surprised Food and Drug Administration officials, who this month began investigating how big a risk the painkiller poses and whether Americans need more explicit warnings to use it safely. They even are seeking data from Britain, where so many people used acetaminophen for suicide that British health authorities now restrict how many tablets are sold at once.
Critics want labels to mention liver failure explicitly, saying consumers don't realize overdosing is easy and dangerous. Lee cites taking maximum doses for days instead of once or twice, or flu sufferers taking high doses while not eating. Also, there are reports that smaller acetaminophen doses may overwhelm hepatitis sufferers.
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