Should Kids Stay Away From Tylenol, Too?

 'One of the most common substances in poisonings.'

When President Donald Trump and HHS Secretary Robert F. Kennedy Jr. recommended against acetaminophen (Tylenol) use during pregnancy earlier this week, they also commented on the medication's use in young children.

Trump warned against giving babies Tylenol during the briefingopens in a new tab or window, and a letter from the FDA to physiciansopens in a new tab or window -- though focused on acetaminophen use during pregnancy -- referenced the developing livers of young children and their potentially limited ability to metabolize the drug.

While there is risk related to acetaminophen and the liver in kids, this is ameliorated simply through proper use of the medication, according to healthcare professionals.

"Acetaminophen is both very safe for and extremely widely used in young children including infants," Jacob Bilhartz, MD, a pediatric hepatologist at University of Michigan Health C.S. Mott Children's Hospital in Ann Arbor, told MedPage Today in an email. "When used after discussing with a physician, in appropriate doses and frequencies, acetaminophen is safe and effective even in children with chronic liver disease or a liver transplant."

"The other commonly used over-the-counter pain/fever medication is the NSAID family of drugs -- ibuprofen being the most common," he said. "These have a higher risk of side effects than acetaminophen including kidney damage, ulcers, and GI [gastrointestinal] bleeding. Acetaminophen is far and away the safest option for children who need first-line pain and/or fever relief."

Bilhartz further noted that acetaminophen has been in use for 70 years. "There is a huge body of experience using this medicine and thus understanding of its risks," he said, adding that he believes it is also "important to emphasize ... the difference between correlation and causation."

"We can make dangerous mistakes by assuming that, just because two things are correlated, one causes the other," he said.

The American Academy of Pediatrics (AAP) fact-checked recent claims about acetaminophenopens in a new tab or window, noting that the medication is safe for children when given as directedopens in a new tab or window. There were a few cautions, though: Kids younger than 12 weeks old should not be given the medication unless instructed by their pediatrician, kids should not be given more than four doses of the medication in 24 hours, and the medication should not be used with any others containing acetaminophen.

J. Routt Reigart, MD, chair of the AAP's Committee on Drugs, said in a statement that with all medications, "it's important to follow dosing directions carefully and under the guidance of a pediatrician."

"There are times when medications may not be necessary, so parents should always talk with their child's pediatrician if they have questions or concerns," he said. "Pediatricians have children's best interests in mind and can help parents and caregivers consider risks and benefits and make the choice that's right for their child."

The AAP also pointed to additional safeguards that have been put in place.

Notably, in 2011, the FDA recommendedopens in a new tab or window that liquid, chewable, and tablet forms of acetaminophen be made in one strength (160 mg/5 mL for infants and children) to reduce the risk of complications.

"Having two very different concentrations of liquid acetaminophen on the market increased the likelihood for dosing confusion and medication errors involving unintentional overdoses in children," FDA stated at the time, adding that unintentional overdoses with the medication can lead to liver injury and death.

In the years since, research has indicated that the single concentration for pediatric liquid acetaminophen and subsequent packaging changes have been associated with a decrease in medication errorsopens in a new tab or window reported to poison control centers.

Still, the potential for acetaminophen toxicity and overdose remains if the medication is not given correctlyopens in a new tab or window.

"Healthcare providers often prescribe children acetaminophen for pain and fever reduction rather than aspirin because of the risk of Reye's syndromeopens in a new tab or window, a rare condition that affects your child's brain and liver," according to the Cleveland Clinic.

"But if a person of any age takes more than the recommended dose of acetaminophen, the result can be acetaminophen toxicity," Cleveland Clinic further noted. "This is a dangerous situation. Your liver can't process excessive doses of the medication. If your child takes too much acetaminophen (or takes the recommended amount for too long), toxins can build up in their body. This toxicity can cause vomiting, liver damage, and death."

Kenvue, the maker of Tylenol, also weighed in following the federal government's announcement.

In a statement strongly disagreeing with any suggestion that acetaminophen causes autism, Kenvue said, "Acetaminophen is also one of the most widely studied pain relievers and fever reducers in infants and children, and numerous randomized, controlled clinical trials support the safety of acetaminophen in infants and children when used as directed."

Regarding the recent remarks on acetaminophen's use in young children, a spokesperson for HHS said, "HHS cannot comment on future or potential policy decisions. The announcement this week pertained to associations between prenatal acetaminophen use and ASD [autism spectrum disorder]."

"President Trump and Secretary Kennedy pledged to practice radical transparency," the spokesperson continued. "HHS is honoring that commitment by following the science and sharing critical public health information as soon as it becomes available, ensuring families are informed and public health is protected."

https://www.medpagetoday.com/pediatrics/generalpediatrics/117652