Acetaminophen, commonly sold under the brand name Tylenol, and antidepressants were responsible for most of the time children were admitted to the hospital for medication poisoning, according to a medicine safety report released by the Pharmaceutical Society of Australia.

Every day, roughly 93 kids in Australia go to the emergency room (ER) for medication-related adverse events, including unsafe off-label use, unexpected drug interactions, accidental poisoning, or overdoses from common household medicines like Tylenol, according to a medicine safety report released by the Pharmaceutical Society of Australia (PSA).

“Given that nearly 100 children present at hospitals each day for adverse reactions, it’s clear that more needs to be done to protect their health,” said the report’s first author Imaina Widagdo, Ph.D., a biostatistics and epidemiology research fellow at the University of South Australia, in a May 28 press release.

Widagdo and her colleagues from the University of South Australia produced the report for PSA, a national professional organization representing over 40,000 pharmacists in Australia.

The report shows that “we need to take much more care when prescribing and monitoring medicines for children and young people,” Widagdo said.

She added:

“Medicines are meant to help — and usually they do. But there are important things that parents and carers need to know. Firstly, unlike adults, children have developing bodies, which means they can respond to medicines differently than adults.

“Secondly, because medicines are rarely trialled with children, the doses, safety and efficacy of certain medicines may not be fully known or always accurate.”

The report drew on data from various studies and a National Health Survey of children ages 0-17 by the Australian Bureau of Statistics.

According to the report, roughly 40 of the 93 children who go to the ER for medication-related problems are admitted to the hospital. About half of both the ER visits and hospital admissions are preventable, the report said.

Overall, the data suggest that medication-related harm among Australian kids costs the country at least $130 million (roughly $84 million in U.S. currency) a year.

“Our health system is failing kids … we must commit to doing better,” wrote Fei Sim, Ph.D., in the report’s foreword. Sim is the national president of PSA and an associate professor at Curtin University.

Australia needs a medication safety monitoring system, group says

Based on its findings, the PSA made several recommendations, including creating a national medication adverse events monitoring program.

The move would bring Australia in line with many of its international peers, including Canada, which has had the Assurance and Improvement in Medication Safety program in place since 2019, noted Sim.

In the U.S., the U.S. Food and Drug Administration (FDA) has used the FDA Adverse Event Reporting System (FAERS) to monitor adverse events from all marketed drugs and therapeutic biologic products since 2004.

The PSA also recommended mandating dosage checks when pharmacists dispense medications for children and teens.

The report looked only at medication-related problems and did not discuss injuries caused by vaccines.

Report ‘missing the big picture’ of how acetaminophen causes autism in kids, expert says

The report revealed other “startling” statistics, including that roughly 120,000 kids under age 14 had a bad reaction to a medicine over six months — and nearly a third were under age 5.

Moreover, roughly seven children a day went to the ER for medication-related poisonings, resulting in about three children a day being admitted to the hospital.

Acetaminophen, commonly sold under the brand name Tylenol, and antidepressants were responsible for most of the time kids were admitted to the hospital for medication poisoning.

“As we see greater incidences of chronic health conditions among children and teens, it’s important for parents and carers to prioritise the safe storage and careful administration of medicines at homes, schools, and childcare,” Widagdo said in the press release.

William Parker, Ph.D. — who for the last 10 years has researched acetaminophen risks — told The Defender the report touches on a “very important issue” by drawing attention to how often kids experience poisoning from common household medications like acetaminophen.

But, at the same time, the report is “missing the big picture,” Parker said.

“It is tragic when one of these preventable things happens,” he said. However, the larger problem — which went unrecognized in the report — is that acetaminophen “is not safe for neurodevelopment … even at clinically accepted doses.”

“It’s causing autism and probably ADHD [attention-deficit/hyperactivity disorder] as well,” Parker said. “So that is the real problem.”

Last month, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. announced a “massive testing and research effort” to determine what causes autism.

The National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services on May 7 announced a “landmark partnership” that will allow NIH autism researchers to analyze the health records of children and adults enrolled in Medicare or Medicaid who have an autism diagnosis.

According to Parker’s research, acetaminophen use is likely a driver of the autism epidemic in kids.

In March 2024, Parker and his colleagues published a peer-reviewed paper tracing “overwhelming evidence” that acetaminophen causes neurodevelopmental harm in babies and children who are predisposed — due to genetic, epigenetic and environmental factors — to process the drug in a way that creates toxicity in their body.

Several lawsuits, known as the “Tylenol lawsuits,” unsuccessfully alleged a link between prenatal acetaminophen use and autism.

According to Parker, the lawsuits failed largely because they only looked at acetaminophen exposure during pregnancy, rather than looking at what happens when babies and small children are exposed to the drug.

Parker said that watching the slow demise of the lawsuits due to lack of admissible evidence “was like watching a train wreck” that he could see coming because the research on prenatal exposure to acetaminophen is relatively limited — most studies employed the same kind of analysis — and doesn’t firmly show that the drug causes ADHD or autism.

Meanwhile, there’s more than a decade’s worth of “compelling evidence” that the drug — when administered postnatally to a baby or child — can cause neurodevelopmental injury that can manifest as autism and perhaps other neurodevelopmental disorders, such as ADHD, Parker said.

The Defender reached out to Widagdo and the PSA for comment but did not receive a response by the deadline.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.