Later, Mc Neil opposed even a modest government campaign to educate the public about acetaminophen’s risks, in part because it would harm Tylenol sales. Tylenol was the pain reliever “hospitals use most,” one iconic ad said.The panel’s recommendation was part of a broader review to set safety rules for acetaminophen, which is still not finished.

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The panel delivered their recommendations on April 5, 1977. Find out more » For its part, Mc Neil has taken steps to protect consumers, most notably by helping to fund the development of an antidote to acetaminophen poisoning that has saved many lives.

Tens of millions of people use it weekly with no ill effect. 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 harm is smaller than for other pain relievers.

But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver. So, too, has Mc Neil Consumer Healthcare, the unit of Johnson & Johnson that has built Tylenol into a billion-dollar brand and the leader in acetaminophen sales.

, from Great Britain to Switzerland to New Zealand, have limited how much acetaminophen consumers can buy at one time or required it to be sold only by pharmacies.

The FDA has placed no such limits on the drug in the U. Instead, it has continued to debate basic safety questions, such as what the maximum recommended daily dose should be.

Davy Baumle, a slender 12-year-old who loved to ride his dirt bike through the woods of southern Illinois, died from acetaminophen poisoning. So did Marcus Trunk, a strapping 23-year-old construction worker from Philadelphia. Yet federal regulators have delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen overdose, which the agency calls a .” The FDA has repeatedly deferred decisions on consumer protections even when they were endorsed by the agency’s own advisory committees, records show.

In 1977, an expert panel convened by the FDA issued urgently worded advice, saying it was .

During the last decade, more than 1,500 Americans died after 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.