505: Use Only as Directed
Sep 20, 2013
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.
Web Extra: McNeil Consumer Healthcare, the maker of Tylenol, chose not to provide a spokesperson for a taped interview for our story. But they did send written answers to our questions and a statement by their Vice President for Medical Affairs, Ed Kuffner. Recognizing that we're a radio show, Kuffner also made a recording of his statement. We excerpt it in our story. Here it is in its entirety.
- 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)
- 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)
- 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)Song: