Medical Author: Melissa Conrad Stöppler, MD
Medical Editor: William C. Shiel, Jr., MD, FACP, FACR
On June 30, 2009, an advisory committee to the U.S. Food and Drug Administration recommended that the FDA restrict the use of acetaminophen, the widely-used pain medication found in products such as Tylenol and Excedrin. Acetaminophen is also referred to as paracetamol in other countries and is a component of in many prescription drugs as well as over-the-counter remedies. The reason for the crackdown is the potential for liver damage that can occur when too much of the medication is taken. Acetaminophen overdoses account for around 56,000 emergency room visits per year in the U.S. and resulted in 356 deaths in 2006.
Taken in recommended doses, acetaminophen is a safe and effective pain-killing (analgesic) and fever-reducing (anti-pyretic) agent. The use of acetaminophen instead of aspirin to treat fevers and other conditions in the pediatric population has greatly reduced the occurrence of Reye's syndrome, an often fatal form of liver failure.
For the average healthy adult, the recommended maximum dose of acetaminophen over a 24 hour period has been considered to be four grams (4000 mg). Each extra-strength Tylenol pill currently contains 500 mg, and each regular strength pill contains 325 mg. Taking about twice the recommended dose can result in liver damage in a healthy person.
How and why do the acetaminophen overdoses occur? Studies have suggested that in the U.S., suicide attempts account for up to 2/3 of acetaminophen overdoses. The remaining cases are due both to unintentional overdose by concurrent use of multiple medications that contain acetaminophen (often without even being aware that the products contain acetaminophen) or recreational abuse of prescription narcotic products that contain acetaminophen.
Some brand-name pain prescriptions containing acetaminophen include:
These drugs are among the most commonly abused prescription drugs. And taking these painkillers together with over-the-counter products containing acetaminophen can also lead to dangerous overdoses. Further, in persons who regularly drink alcohol or who have previous liver damage, even the recommended maximum daily doses of acetaminophen may be too high and may cause liver problems.
The FDA advisory panel isn't trying to eliminate the use of acetaminophen, but has suggested restrictions on its use that will reduce the recommended dosages and eliminate some popular prescription products that contain acetaminophen. Specifically, the advisory committee:
- Recommended that the single adult acetaminophen dose should be no more than
650 milligrams, (two "regular strength" Tylenol tablets as opposed to two "extra
strength" tablets containing 1000 mg)
- Recommended that the 1000 mg dose of acetaminophen be available only by
- Recommended that the maximum daily dose of 4000 mg be lowered (but did not
recommend a new daily maximum)
- Recommended that prescription drug products that combine acetaminophen with other painkillers such as narcotics, such as Vicodin and Percocet, be eliminated. If these are not eliminated from the market, the panel recommended that they carry a "black box" warning about the potential for acetaminophen overdose.
Industry representatives and some pain management specialists have expressed concerns about eliminating many drugs that have been successfully used for pain control in millions of cases. The FDA is not required to follow the advisory committee's recommendations and will consider their recommendations before issuing a final ruling.
FDA, "Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee Meeting Announcement," June 29-30, 2009