Recently ProPublica and This American Life (TAL) released the results of an investigation into acetaminophen, the active ingredient in Tylenol. TAL devoted an entire episode to the issue, and ProPublica has published several stories on acetaminophen’s toxicity, how it can cause harm, and how it is regulated.
The investigation summarizes the key “Takeaways” as follows:
- 150 Americans die per year from accidental acetaminophen overdoses
- The safety margin (safe dose vs. toxic dose) with acetaminophen is small
- Both the FDA and the manufacturer, McNeil, have known about the toxicity for years
- For over 30 years the FDA has failed to implement measures to reduce the risk of harms it knew existed
- The manufacturer has taken steps to protect consumers but has also opposed other safety measures
While Tylenol is a single brand out of hundreds of prescription and non-prescription products that contain acetaminophen as an active ingredient, it is the brand most closely associated with the chemical. Amazingly for a drug that has no patent and lots of competition, Tylenol products are estimated to make up half of all non-prescription acetaminophen sales in the US, a testament to the power and effectiveness of marketing. (It’s also a clear refutation to alt-med arguments that unpatented products can’t be profitable, or aren’t of interest to the pharmaceutical industry.) While much of the focus of the investigation centers on the corporate behavior of Tylenol’s manufacturer, McNeil, (a division of Johnson & Johnson), it is important to keep in mind that no single company is responsible for acetaminophen sales and marketing. (more…)