Some patients concerned over new recommendations for acetaminophen use

Brandon Johnson takes acetaminophen for headaches. When he had his wisdom teeth removed, and burst a blood vessel in his eye, his doctor prescribed Vicodin, a pain medication containing acetaminophen.
A lot of people take ibuprofen for aches and pains or fever, but that's not an option for Johnson.
"When I take it, my body just starts to hurt really bad," the Brigham City man said. "I feel like I can't breathe, and it starts to make me really sick."
So when federal Food and Drug Administration advisory committees recommended new restrictions on the use of acetaminophen, Johnson was concerned.
"There was a lot of discussion at the FDA advisory committee meeting about unintended consequences for people who are allergic, or have other health issues, and need to be taking acetaminophen," said Elaine Morrato, assistant professor at the University of Colorado in Denver, and a committee member.
The FDA has not made any final decisions. When they do, one thing is certain:
"Acetaminophen is not going away," said Erin Fox, manager of University of Utah Hospital and Clinics' Drug Information Service.
Recommendations
The FDA committees met at the end of June to discuss acetaminophen and liver damage.
Acetaminophen, the generic name of the drug in Tylenol and similar products, is one of the most commonly used drugs in the U.S. It's often combined with other drugs in over-the-counter and prescription medications.
According to information on the FDA Web site, www.fda.gov, acetaminophen is generally safe when users follow directions. However, taking more than the recommended amount can cause liver damage -- or even death.
Committee members voted on ways the FDA might deal with the problem, and those ranked highest were:
SBlt Lowering the maximum nonprescription single dose for adults, and total daily dose
SBlt Eliminating prescription acetaminophen combination products
SBlt Making only one concentration of nonprescription acetaminophen liquid
SBlt Putting a boxed warning on prescription acetaminophen combination products
Eliminating over-the-counter combination products was discussed, but that idea was more controversial.
Lower doses
The present maximum total daily dose of acetaminophen is 4,000 milligrams. According to the FDA, exceeding that dose, even by a small amount, can cause liver damage. People who use alcohol may have greater sensitivity to the effects.
According to a report at the Web site of the nonprofit Institute for Safe Medication Practices (www.consumermedsafety.org), acetaminophen overdose results in 56,000 emergency visits, 26,000 hospital stays, and 458 deaths per year.
The FDA says there is only limited agreement on the specific threshold dose for toxicity. Committee members voted to lower the single dose from 1,000 to 650 milligrams, and to lower the maximum daily dose, but there was no vote on a specific amount for the new maximum daily dose.
Morrato says anyone who has to take acetaminophen long-term for pain management, even in nonprescription strength, should talk to his/her physician about the appropriate dose.
"I have no problem with them adjusting the single dose to be 650 milligrams, instead of 1,000," said Dr. Bryan Richards, an otolaryngologist, plastic surgeon and allergy specialist from Layton.
Combination drugs
Richards does have a problem with the idea of eliminating products that combine acetaminophen with other drugs.
"Acetaminophen works as a great adjunct with narcotic painkillers, like the main ingredient in Lortab or Percocet. It has a synergistic effect," he said, explaining that the combination means patients need less narcotic.
The problem is that many people don't pay attention to what's in combination drugs.
"Some people overdose unintentionally," said Fox. "It's more, 'Gosh, I have a headache, so I'll take Extra Strength Tylenol, and the reason I have a headache is because of a head cold, so I'll take NyQuil, too."
And they may take them at the same time as prescription drugs.
"On the prescription bottle, it may not clearly state that it contains acetaminophen," said Fox.
Many labels, prescription and nonprescription, use the abbreviation "APAP" instead of acetaminophen's longer name, N-Acetyl-p-Aminophenol, she said.
Dr. Bruce Thomas, with a practice in sports medicine, arthroscopy and reconstructive surgery in Ogden, says discontinuing the combination prescription drugs is potentially a good idea.
"We'll have to get used to how well our pain medications work without Tylenol in it," he said. "But it will be easier to gauge how much Tylenol you're taking. ... You'll know when you're taking Tylenol, and when you're taking other pain medications."
A comment on the FDA Web site, posted by a dentist, expresses concern that with Vicodin and Tylenol #3 removed from the market, people with allergies to aspirin and ibuprofen will be prescribed more addictive Schedule II drugs.
"Percocet is a Schedule II substance," said Fox. "As a rule, Schedule II drugs are thought to have higher addiction potential ... but I don't think anyone can argue that between Vicodin and Percocet."
Liquids
The recommendation to make liquid acetaminophen in only one strength passed with only one "no" vote.
"Tylenol infant drops are very concentrated, and then Tylenol children's syrup is a different strength," said Fox. "If you accidentally gave a child who needed syrup the infant version, you could unintentionally give the child too much."
Warnings
The recommendation to put a boxed warning on acetaminophen products also received only one opposing vote, but Richards isn't convinced it's the way to go.
"Tylenol is one of the safest and most useful medicines, and to put a black box warning on it is just ridiculous," he said. "Americans need to get it out of their heads that they can take medicine without any risk of side effects, and Americans need to stop trying to protect Americans from every adverse event that could happen."
Richards says the key is teaching people that they can't have more than a certain dose per day, and to watch for it on every label.
Thomas says some people read labels, but others don't.
"I just finished four nights in a row on call, and two of the patients couldn't tell me what dose they're on for their medications; their families had to go home and get the bottles" he said.
Johnson says he isn't convinced warnings or education are going to make a difference.
"People are kind of dumb. Even if you educate them, they're going to abuse everything you give them," he said.
Public comment on the recommendations will be accepted until Sept. 30. Electronic comments can be submitted at www.regulations.gov. Send written comments to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. For questions about submissions, call (301) 827-6860.