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Accidental acetaminophen overdoses spur little FDA action, report says

Acetaminophen — perhaps best known as being the active ingredient in Tylenol — is the most-used drug in the United States.

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.

In 1977, an expert panel convened by the FDA issued urgently worded advice, saying it was “obligatory” to put a warning on the drug’s label that it could cause “severe liver damage.” After much debate, the FDA added the warning 32 years later. The panel’s recommendation was part of a broader review to set safety rules for acetaminophen, which is still not finished.

Four years ago, another FDA panel backed a sweeping new set of proposals to bolster the safety of over-the-counter acetaminophen. The agency hasn’t implemented them. Just last month, the FDA blew through another deadline.

Regulators in other developed countries, 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.S. Instead, it has continued to debate basic safety questions, such as what the maximum recommended daily dose should be.

For its part, McNeil 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.

But over more than three decades, the company repeatedly fought against safety warnings, dosage restrictions and other measures meant to safeguard users of the drug, according to company memos, court records, documents obtained under the Freedom of Information Act, and interviews with hundreds of regulatory, corporate and medical officials.

You can read the report, “Use Only As Directed,” in full at ProPublica’s website. It contains several side articles that can help you determine how much acetaminophen you’re taking. (The drug is in cold-and-flu medications as well as in single-ingredient pain relievers.) The report also includes a discussion about acetaminophen and child safety — an important read for parents.

ProPublica co-reported this story with the public radio show “This American Life,” which released its broadcast on the topic last Saturday. You can listen to it here.

Comments (1)

  1. Submitted by Paul Brandon on 09/23/2013 - 07:11 pm.

    And to complicate it further

    The safe dosage for a 70 year old 100 lb woman would be a lot less than that for a 200 lb 30 year old man.
    Ideally, the dosage should be individualized by a physician or pharmacist well grounded in pharmacology (which is not the same as pharmacy).

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