The FDA empaneled some 37 experts to assist in the reduction of deaths due to acetaminophen overdose. Huh? Tylenol? Yes, Tylenol. Acetaminophen overdose is the leading cause of liver failure in the United States causing 200 deaths annually with 56,000 in the ER.

One of the main recommendations of the panel was to lower the current maximum daily dose from 4 grams (8 pills) and limiting any single maximum dose to 650 mg, from 1000 mg (2 Extra Strength Tylenol). Additional recommendations included making Extra Strength Tylenol a prescription drug.

The industry, J&J and Wyeth mostly, felt the current dosing and labeling appropriate. Surprise. Sales of acetaminophen-based painkillers are estimated at around $2.6 billion for last year alone. 80% of which are over-the-counter medications.

The same panel also recommended banning Vicodin and Percocet. To be continued. . .

posted by David Marc Schwadron, Esquire