FDA advisers look to restrict acetaminophen

DATE: 01 Jul 2009
A panel of experts has recommended the FDA restrict levels of acetaminophen in Tylenol and other pain killing over-the-counter drugs

Advisory groups recommend the FDA to restrict the over-the-counter dosage of acetaminophen - the main ingredient in many pain killing medications.

By Gabe Perna

You might not know what acetaminophen is or what it does. However, chances are you've used products which contain it. Does Tylenol ring a bell? Perhaps Excedrin? Acetaminophen is the main ingredient in these popular over-the-counter pain killing medications. Yesterday, a panel of health advisers sent a recommendation to the FDA that they reduce levels of acetaminophen in Tylenol and other pain-killing drugs.

The panel voted 21-16 to reduce the maximum daily dose of nonprescription acetaminophen. Current at four grams - equal to eight pills of a drug such as Extra Strength Tylenol - they were not asked to give a recommended amount. They also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. It's at 1,000 currently for Extra Strength Tylenol. They recommended 1,000 be available only by prescription.

So what is the reasoning for these recommendations? The panel says extreme dosages of acetaminophen can cause severe liver damage and even death in some cases. 56,000 people are sent to the emergency room for this year every year and 200 people die because of it. The experts also voted to ban prescription drugs such as Vicodin and Percocet.

In a statement responding to the reports, Tylenol Senior Medical Director, Edwin K. Kuffner, said, "The safety and efficacy of acetaminophen has been established through more than 50 years of clinical use and scientific investigation and it is safe when used as directed." Johnson and Johnson, producer of Tylenol, said in a statement that it "strongly disagrees" with the recommendations to place restrictions on acetaminophen.

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