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Want Tylenol? You may need prescription

June 30, 2009 12:00:00 AM PDT
An FDA panel is urging cuts in acetaminophen dosages. Let's say you've got headache or a bad cold and you start taking some Tylenol or generic acetaminophen. The label says adults can take two pills every four hours. That's about eight pills a day, which is the current recommended daily dosage, but now an FDA advisory panel says that's way too much.

The panel is recommending drug makers lower the dose from 500 mg a pill to 325 mg. If the FDA agrees, that would mean a complete overhaul of what you see in the drug store.

"If we reduce the tablet size from 500 mg to 325 mg that would have tremendous implications and would mean most over-the-counter would have to be removed from the market," said Dr. Judith Kramer, Duke Medical Center.

The concerns are over possible liver damage from over-medication. The panel also voted to limit the maximum single dose to 650 mg, and suggested the current maximum of a 1,000 mg become a prescription.

Researchers believe acetaminophen is likely responsible for 1,600 cases of acute liver failure each year.

In response, the makers of Tylenol say: "McNeil Consumer Healthcare strongly disagrees with the committee's recommendation. McNeil Consumer Healthcare believes that this recommendation is likely to lead to more serious adverse events as consumers shift to other over-the-counter products."

The advisory panel is also calling for opioid-acetaminophen combinations such as Vicodin and Darvacet to be eliminated. The panel recommended removing those combination drugs from the market.

"If we're trying to save lives of the people who have unintentional overdoses, this is the best way to do it," said Dr. Neil Farber, UC San Diego.

But acetaminophen is also in many over-the-counter cold medications, and while officials warned of overdosing they did not advocate an outright ban of those products.

Products like Nyquil or Excedrin contain 250 mg per pill, which would fall under the new recommended doses. Acetaminophen has been on the market for 50 years and a pain medication many doctors recommend.

The makers of Tylenol are strongly urging the FDA not to follow the recommendations of the advisory panel.

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