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Most Unaware How Small a Dose of Acetaminophen Can Injure Liver, Cause Death

Filed September 23rd, 2013 Laurie

Tens of millions of people take Tylenol, a drug widely considered safe, on a daily basis, blissfully unaware of the fact that the drug’s active ingredient, acetaminophen, can cause serious side effects and death at not especially large doses.

According to, more than 1,500 Americans have died of an acetaminophen overdose in the past decade. The U.S. Food and Drug Administration (FDA) knew for decades that the difference between a safe and potentially harmful dose of acetaminophen is not much. The call for a label warning of “severe liver damage” first rang out in 1977, but it took until 2009, for it to be placed on the drug’s packaging. The FDA admitted to moving too slowly on the issue.

The FDA says acetaminophen carries a greater risk when used improperly than aspirin or ibuprofen. Acetaminophen has been linked to more deaths than any other over-the-counter pain (OTC) medication and is the cause of 33,000 hospitalizations each year. Even so, McNeil Consumer Healthcare – the maker of Tylenol – asserts the drug is safe when used as directed, reported.

Four years ago, an FDA panel supported a new set of proposals to make OTC acetaminophen safer, but the agency has not implemented them. The FDA missed yet another deadline in August, according to advocacy group

The FDA says about a quarter of Americans routinely take OTC pain pills more often than they’re supposed to, and describes this behavior as “particularly troublesome.” According to the agency, a large fraction of users regularly take a near-toxic dose. Taken over several days, as little as two additional extra-strength pills can cause liver damage. Taken all at once, a little less than four times the maximum daily dose can cause death, reported.

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