September 20, 2013

Use Only as Directed

One of the country's most popular over-the-counter painkillers — acetaminophen, the active ingredient in Tylenol — also kills the most people, according to data from the federal government. Over 150 Americans die each year on average after accidentally taking too much. And it requires a lot less to endanger you than you may know. We reported this alongside ProPublica. Their stories here and here.

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Transcript

Prologue

Host Ira Glass tells the story of Sarah Erush, a pharmacist at the Hospital of the University of Pennsylvania. She was contacted by the Food and Drug Administration and encouraged to examine cases of acetaminophen overdose at her hospital. Erush was surprised by how little over the recommended dose of the drug resulted in liver damage and, for three patients, death. (10 minutes)

Act One

Reporter Sean Cole tells the history of getting warning labels onto acetaminophen bottles. In 1977 an FDA advisory panel recommended a warning about liver damage. It took 32 years before the FDA took their advice and mandated a label. As Cole notes: "The drug approval process is usually slow but not usually this slow. The FDA began with acetaminophen over 40 years ago in 1972. In that time, science has mapped the human genome, eradicated smallpox, we’ve cloned a sheep. And yet we still have not come up with final rules for safe usage and labeling of one of the most popular drugs in the country, of which more than 20 billion doses are sold each year." (24 minutes)

By

Sean Cole

Act Two

Reporter Sean Cole explains the confusion over dosing for Infants Tylenol and Children’s Tylenol. The FDA could have mandated clearer labels that might have prevented infant deaths. But it chose not to, despite the urging of Tylenol’s manufacturer McNeil Consumer Healthcare. McNeil, for its part, could have pulled one of the products from the shelves, but it chose not to. (18 minutes)