- The Washington Times - Wednesday, July 8, 2009

CHICAGO (AP) | 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 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.

For those on Tylenol, the short answer — from Dr. 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-to-be-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.

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 Dr. 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.”

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.

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