FDA Experts Propose Changes for Acetaminophen

A panel of 37 FDA experts convened and recommended several changes to ensure the safe use of acetaminophen, the popular arthritis pain reliever known also by its brand name, Tylenol. The concern stems from a high number of acetaminophen overdoses. Too much acetaminophen can result in liver failure and death.

Experts voted 21-16 to reduce the maximum daily dose of acetaminophen from the current 4 grams/day. They also recommended lowering the maximum single dose from 1000 mg to 650 mg. The possibility of eliminating certain combination painkillers like Percocet and Vicodin also was proposed. Such drugs contain acetaminophen plus another active ingredient to control pain.

If combination products are not eliminated, they could instead carry a black box warning (the strongest warning issued by the FDA) or the level of acetaminophen in them could be reduced. If the combination painkillers are eliminated, their ingredients still could be sold separately. Pulling cough and cold medicines that contain acetaminophen off the market was also considered -- but was not recommended. While the FDA is not required to follow recommendations of the advisory committee, it usually does. No date was given regarding when final decisions will be made.

Related Resources:

• Acetaminophen - 10 Things You Should Know
• Cumulative Effect of Acetaminophen
• The Facts of Analgesics (Painkillers)
• What Is Extra Strength Tylenol?
• What Is Tylenol Arthritis Pain?

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