Image: Sharon Waldrop and son Jack
Carlos Osorio  /  AP
Sharon Waldrop helps her son Jack in his car seat in Royal Oak, Mich., on Tuesday. Waldrop takes Tylenol regularly for severe muscle pain. She knows about liver damage risks but says she "could not get by" with the proposed reduced doses.
updated 7/7/2009 6:52:28 PM ET 2009-07-07T22:52:28

Proposed limits on Tylenol, a painkiller as common as pain itself, have left many consumers fearful, confused and wondering where to turn for relief. The potential government crackdown on acetaminophen, Tylenol's main ingredient, would affect everyone from occasional pill poppers to chronic pain sufferers who rely on daily doses to make their lives more bearable.

If adopted by the Food and Drug Administration, the changes would lower the maximum over-the-counter Tylenol dose and would ban two narcotic painkillers, Vicodin and Percocet, which also contain acetaminophen.

Yet another painkiller, propoxyphene, was the target of FDA action on Tuesday. Also sold as Darvon and in an acetaminophen combination called Darvocet, it has been linked to accidental overdoses and suicides. The prescription medication will now come with a pamphlet describing the risk.

Sharon Waldrop, a mother of two young boys in Royal Oak, Mich., takes Tylenol regularly for severe muscle pain. She knows about liver damage risks but says she "could not get by" with the proposed lower doses.

Karen Palmer of Cincinnati takes Percocet for debilitating rheumatoid arthritis and says it took five years to find medicine that really helps. "I don't want to have to go through that all over again," said the 46-year-old hotel worker, on disability because of the disease.

Dr. Ronnie Mandal, an internist at Chicago's Swedish Covenant Hospital, says he's gotten calls from worried elderly patients who saw the news on TV last week.

"Most of them are wondering, is it safe for me to use?" he said.

How much is too much?
For those on Tylenol, the short answer — from Mandal and other physicians — is yes, if used judiciously. Doctors say there's no reason to switch to other pain relievers, which can cause different problems.

But avoiding an acetaminophen overdose requires reading medicine bottles scrupulously and doing a little math because acetaminophen is often a hidden ingredient. Popping a few extra pills or mixing Tylenol with other medicines can quickly add up to too much. So can taking any of these drugs while drinking alcohol, which aggravates effects on the liver.

For users of the proposed banned narcotic drugs, which one liver expert likened to candy mixed with poison, options would be more limited, particularly given other recent clampdowns on narcotic painkillers.

"If these drugs were not available to our patients, there would be a stampede toward the doctor to try to figure out an alternative treatment for them because they're such widely used drugs," said Dr. Gil Fanciullo of the American Pain Society.

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The results could be undertreatment of pain, or putting patients on even stronger narcotics. Better labeling of medicines that have acetaminophen is the answer, rather than making them less available, said Fanciullo, a pain management specialist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Dave Duhrkoop, a retired marketing manager in Troutdale, Ore., has taken Vicodin and Percocet for severe back pain. He's now on a different drug but thinks banning the other two would be overkill. It could lead chronic pain sufferers to turn to street drugs "because people don't want to hurt."

Overdose concerns
According to the FDA, prescription acetaminophen combination drugs were prescribed 200 million times last year. Tylenol's maker says nearly 50 million U.S. adults and children take acetaminophen in any given week.

The panel's proposals, announced June 30, were prompted by concerns over acetaminophen overdoses, which are the leading cause of liver failure. They sicken more than 50,000 people and cause at least 200 deaths each year nationwide.

Poisoning is not believed to be a risk for long-term users of recommended Tylenol doses, and they do not need liver tests, said Dr. William M. Lee, a liver disease specialist at the University of Texas Southwestern Medical Center in Dallas.

Liver problems associated with excessive use of Tylenol and other forms of the drug tend to occur suddenly. They typically show up within about three days of taking extra doses, Lee said, and even a few extra pills over a few days can cause problems.

That's why the FDA panel recommended making the current maximum single dose of Tylenol, 1,000 milligrams, available by prescription only. The new maximum single dose would be 650 mgs. The total daily limit would be cut from 4 grams, about 12 regular-strength Tylenol pills, to an unspecified lower dose.

Symptoms of liver problems include nausea, vomiting, upper abdominal pain and jaundice. With immediate treatment, permanent liver damage can be prevented.

Safe when used as directed
The recommendations led Tylenol's manufacturer to run full-page ads in major newspapers Friday declaring the medicine is safe when used as directed. The ads also say never take more than recommend doses, and don't use two products containing acetaminophen at the same time. That includes over-the-counter cold medicines such as Nyquil and Theraflu, and prescription medicines also containing the drug.

The Arthritis Foundation issued a statement supporting the limits, saying that arthritis patients "must be made aware of potential side effects of drugs so they can decide about the level of risk they are willing to accept."

Lee, the Dallas liver specialist, also supports the proposed limits. He provided data on acetaminophen poisoning to the FDA advisory panel.

The full FDA is considering the recommendations, but any final decisions are months away.

The proposed ban on Vicodin and Percocet is justified because they're so easy to abuse, Lee said. The narcotics in these drugs are addictive and can lead users to take increasingly higher doses — but that also means increasingly higher amounts of acetaminophen.

Quoting a colleague, Lee said it makes no sense to combine a highly addictive drug with a "dose-related poison. It's like putting poison and candy together."

Oxycodone, the narcotic in Percocet, can be prescribed separately. But Vicodin's narcotic ingredient is hydrocodone, which isn't available alone.

The risks for liver failure justify the restrictions, Lee said.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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