During the last decade, more than 1,500 Americans dieda fter accidentally taking too much of a drug renowned for its safety:acetaminophen, one of the nation’s most popular pain relievers.
Acetaminophen – the active ingredient in Tylenol– is considered safe when taken at recommended doses. Tens of millions of people use it weekly with no ill effect. But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver.
Davy Baumle, a slender 12-year-oldwho loved to ride his dirt bike through the woods of southern Illinois, died from acetaminophen poisoning. So did tiny five-month-old Brianna Hutto. So did Marcus Trunk, a strapping 23-year-old construction worker from Philadelphia.
The toll does not have to be so high.
The U.S. Food and Drug Administration has long been aware of studies showing the risks of acetaminophen – in particular, that the margin between the amount that helps and the amount that can cause serious harmis smaller than for other pain relievers.
So, too, has McNeil Consumer Healthcare, the unit of Johnson & Johnson that has built Tylenol into a billion-dollar brand and the leader in acetaminophen sales.
Yet federal regulators have delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen overdose,which the agency calls a “persistent, important public health problem.”
The FDA has repeatedly deferred decisions on consumer protection seven when they were...