- Tylenol (acetaminophen) is the leading cause of liver failure in the U.S. The death rate from overdosing on Tylenol (roughly 150 to 200 per year) increased seven-fold between 1995 and 2005.
- Starting in summer 2009, McNeil (part of Johnson & Johnson) tried to push back against additional FDA restrictions on the drug, according to ProPublica. At that point, J&J was spending roughly $6.5 million per year on lobbying efforts for Tylenol.
- There are currently more than two hundred lawsuits pending in state and federal courts from plaintiffs alleging harm from Tylenol without proper disclosure of risks from McNeil.
For 38 years, the FDA has been having hearings on Tylenol, and they are stll ongoing. At one heated moment in summer 2009, the FDA convened a panel of scientists, researchers, and pharmacists to review the safety of acetaminophen.
The panel ultimately recommended a series of reforms, including making Extra Strength Tylenol available by prescription only. This generated a great deal of pushback from McNeil, which sought to protect its financial interests. While regular strength Tylenol generates about $14 million per year in revenues, sales of Extra Strength Tylenol are around $400 million.
McNeil fought back against having the FDA impose dosage restrictions and warnings on the label, and even tried to thwart public awareness campaigns. The death rate from overdosage increased and the lawuits multiplied, culminating in the trial starting today (Wednesday) between McNeil and Regina Jackson, who claims she was hospitalized with elevated liver enzymes after taking too much Tylenol without knowing that she was exceeding a safe dose.
The big question is whether this trial and others will lead to further regulations on how Tylenol is labeled. Currently, the maximum recommended dose is four grams per day, which is eight tablets; however, some researchers have noted risk of serious liver damage from taking two extra pills for several days. This issue has been in the media spotlight for several years, but finally, it seems that the FDA may be able to impose stronger regulations on McNeil—depending on the decision of the jury.