A Warning About Children and Acetaminophen
The baby was teething. Fussing and crying, the 8-month-old was awake all hours of the night. Not even doses of the Tylenol for babies seemed to help.
So the child’s worried father did what he thought was best: He gave his son a stronger dose--crushing adult Tylenol tablets and putting them in with the baby’s bottle.
“The baby was crying much more than normal,” said the Arleta man, who asked not to be identified. “The baby Tylenol had no effect.”
Three days later, the child was comatose and near death from an accidental overdose that experts say happens several dozen times each year in the United States: Parents give their ill children too much of the pain-reliever acetaminophen.
In the past year, Dr. Sue McDiarmid, director of the Pediatric Liver Transplant Program at UCLA Medical Center, has performed two emergency liver transplants on local children because they were given too much acetaminophen for mild illness or fever. Last month, she also treated the 8-month-old baby, who recovered without the need for a liver transplant.
Although this type of overdose is rare, McDiarmid wants to get the message out loud and clear during this harsh flu season: Too much acetaminophen can result in liver failure and even death.
“This type of accident is totally preventable,” she says. “Parents are giving too much, too often, over several days. It’s a chronic poisoning.”
These accidents have also led to suggestions that labels on acetaminophen--sold under the brand name Tylenol as well as many generic brands--should be changed to be more specific about the potential dangers.
But a spokesman for the manufacturer of Tylenol, McNeil Consumer Products Co., says: “These cases of acetaminophen toxicity are extremely rare, and invariably, are associated with misuse of the product. We feel our labeling is unequivocally clear. We do not see any need to change this label.”
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Acetaminophen is considered a safe drug when taken according to directions. It is commonly prescribed for fever, minor aches and pain, and irritation, and it is highly effective.
Perhaps because it so commonly prescribed, overdoses have become more common, says Dr. Ronald W. Busuttil, chief of liver transplant services at UCLA. But few people recognize the dangers of taking too much acetaminophen.
“The number of overdoses has probably gotten worse because so many medicines have acetaminophen in them nowadays,” he says. “There needs to be an understanding that, although acetaminophen is a good drug, we have to be cautious. If we abuse it, the consequences are tragic.”
Equally important, McDiarmid says, is that parents should buy the right product for the right age group and “follow the directions to the letter.”
Medicines vary in strength according to the ages for which it is intended. Most products for adults do not give dosage levels for children under 12.
“Too many parents think, ‘If we don’t have the pediatric acetaminophen, we’ll just give the adult acetaminophen, but we’ll give less.’ ”
It is difficult to determine just how many children become seriously ill from this particular type of acetaminophen overdose, McDiarmid says. The National Poison Control Center reported 40,000 cases of acetaminophen overdoses in 1992, most of which were not serious. For example, in many cases the child was given--or took--one extra dose, which is not usually harmful.
But at least several dozen probably involved chronic poisoning. A doubling of the correct dose given every four hours for two days can cause toxic levels and destroy the liver, McDiarmid says.
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Children’s bodies have an enormous capacity to handle an overdose of acetaminophen without serious consequence--even more so than adult bodies, in part because children’s livers are healthier. But what is so tragic about these rare cases, McDiarmid says, is that by the time the overdose is discovered, the child is often near death and needs a liver transplant to survive.
What usually happens is that the child recovers from a mild illness, such as influenza, and the parent stops giving the drug. But 24 to 72 hours later, the child gets sleepy and may even act bizarre or aggressive. Seizures and vomiting may occur.
“Because the child had seemed fine before, people have a false sense of security that it didn’t involve the acetaminophen,” McDiarmid says. “Parents and doctors can really get fooled.”
This delay between the time the acetaminophen is stopped and the overdose symptoms appear is due to the long time required for the body to metabolize the drug, she says.
If the overdose is discovered before the symptoms set in, a medication can be given to prevent liver damage. But, she says, “this antidote has to be given within 16 hours of the overdose. So it’s unlikely to be of much help. The horse is already out of the barn and down the road.”
Once the poisoning is recognized, a liver transplant is usually required to save the child, she says. That means taking whatever liver is available, including one that might not be the best match.
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UCLA doctors say Nathan Card, 6, was lucky to have received a donor liver on Oct. 28, 1993, when he was near death from acetaminophen poisoning.
His mother, Carrie Ackley of Yucaipa, had given the child Tylenol frequently for a fever and ear infection.
But three days later, Nathan started vomiting. By the next day, he was in a coma. He recovered after a liver transplant.
“I can’t figure it out,” Ackley says. “I can’t understand how, in 24 hours, he could have gotten so much (better) and could have gotten so ill. I had no idea that (acetaminophen) could do such a thing. I would have thought that there would have been a huge warning label that you can have liver failure and die.”
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The UCLA doctors say parents need to learn that acetaminophen can be toxic when given in overdose levels and to be careful when providing the drug. But they also say they would prefer a more specific label warning.
The labels on Tylenol products state: “Keep this and all medications out of the reach of children. In case of accidental overdose, contact a physician or poison control center immediately.”
“I think the label needs to be changed to say, ‘If the recommended dose is exceeded, liver failure or death can occur,’ ” McDiarmid says. This kind of warning, she says, would be more in line with the specific warnings on aspirin products, which state that aspirin can cause Reye’s Syndrome, a potentially fatal illness, in young children.
The U.S. Food and Drug Administration has also taken notice of the problem. In January, 1992, FDA commissioner David Kessler warned parents that many over-the-counter medications, such as multi-symptom cold and flu products, contain acetaminophen. A child might get an overdose if given regular acetaminophen plus one of these products.
The manufacturers of acetaminophen point out that they produce many different preparations for different age groups to ensure that overdose doesn’t occur.
That is what happened to the Orr family of Simi Valley. A year ago, Crystal Orr, then 5, received a liver transplant at UCLA after her parents gave her an accidental overdose of adult Tylenol. Crystal, ill with a fever of 102 degrees for several days, had been given Extra-Strength Tylenol Caplets. Two tablets contain 1,000 milligrams of acetaminophen.
According to the Orrs’ attorney, Bob Scott, Troy and Sandy Orr gave her half the adult dose, 500 milligram, about every four hours for a period of about two days.
But, a 5-year-old child should receive a dose of about 240 milligram.
The Orrs are suing the manufacturer of Tylenol, charging that specific warnings should be on all acetaminophen products so that parents are warned to avoid using the drug liberally or guessing about dosages.
“It was the middle of the night and the child was in great discomfort (from strep throat),” Scott says. “They were trying to figure out what to give her to get her to the morning. The bottle they looked at had no dosage levels for children under 12. But because they were familiar with Tylenol and comfortable with it, they saw no reason to believe there was a great risk in it. They gave her half the adult dose.”
Jeff Leebaw, a spokesman for the manufacturer of Tylenol, said the company will not comment on pending litigation. But, he said: “As for Extra-Strength Tylenol, the labeling states the product is for adults and children 12 years and older.”
Crystal is doing well with her new liver but, like all transplant recipients, she will spend her life on special medications and must avoid germs that can threaten her immune system. And, 10% of all liver transplant recipients require a second transplant due to rejection or failure.
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McDiarmid says the anguish that parents endure after realizing that they’ve given their child an overdose is almost as horrible as what the child experiences.
The father of the 8-month-old child suspected that he had misused the acetaminophen after his child fell into a coma.
“It was hard for me to even say, ‘Yeah, I gave him adult Tylenol,’ ” the father says. “But I told myself, ‘My baby is sick. I have to tell the doctors.’ I had no idea (acetaminophen) could be so harmful. I thought, the more, the better.”
“The torment that these parents go through is awful,” McDiarmid says. “They are so devastated because they thought they were doing the right thing.”
Acetaminophen and Children
* Consider whether the medication is even needed, such as in the case of a mild fever. If you are not sure, ask your doctor.
* Remember that acetaminophen is a drug and that too much of it can be toxic.
* Never exceed the dosage listed on the bottle.
* Always buy the age-appropriate preparation. Never give the adult product to children under 12.
* If you are afraid you have given a wrong dose, don’t panic. Call a doctor or call a poison control center. Southern Californians can phone the Los Angeles Regional Drug and Poison Information Center at (800) 777-6476.
Source: Dr. Sue McDiarmid, UCLA
