Newspaper article

Accidental Acetaminophen Overdoses Spur Little FDA Action, Report Says

Newspaper article

Accidental Acetaminophen Overdoses Spur Little FDA Action, Report Says

Article excerpt

Acetaminophen -- perhaps best known as being the active ingredient in Tylenol -- is the most-used drug in the United States. Americans took some 29 billion doses of the pain reliever in 2009. Few Americans realize, however, that acetaminophen has a narrow safety margin.

Taking as little as 25 percent more than the maximum recommended dose of the drug has been reported to cause acute liver failure. (In some cases, that excess dosage is the equivalent of only two additional extra-strength pills a day.)

Indeed, acetaminophen overdoses are a significant -- and potentially deadly -- public-health problem in the United States. Each year, such overdoses send some 78,000 people to U.S. hospital emergency rooms and lead to 33,000 hospitalizations.

U.S. deaths from accidental (non-suicide) overdoses of acetaminophen are uncommon, but still significant: an average of 150 each year.

The tragedy, of course, is that those deaths could have been avoided.

That message -- and all the above statistics -- are from an excellent and disturbing investigative report released Friday by the nonprofit journalism group ProPublica. It's a report all health consumers (which means everybody) should read, particularly because, as ProPublica's reporters Jeff Garth and T. Christian Miller point out, about 25 percent of Americans use more than the recommended doses of over-the-counter pain relievers.

Here's the reporters' summary description of their investigation:

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 harm is 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 protections even when they were endorsed by the agency's own advisory committees, records show. …

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