Health Canada Says Tylenol Safe During Pregnancy, Rebuffs US FDA Autism Concerns

Tylenol in a store in New York City on Sept. 5, 2025. Kylie Cooper/Reuters

Health Canada says there is no evidence that using Tylenol during pregnancy can cause autism or other neurological disorders in children.

The agency made the comments after the U.S. Federal Drug Administration (FDA) said there may be a link between acetaminophen and autism. Acetaminophen is the active ingredient in Tylenol, which is used as a pain and fever reliever.

“Health Canada currently maintains that there is no conclusive evidence that using acetaminophen as directed during pregnancy causes autism or other neurodevelopmental disorders,” Health Canada said in a Sept. 23 statement.

It said its advice was based on “robust, rigorous assessments of the available scientific evidence,” adding any new evidence would be “carefully evaluated.”

The FDA notified U.S. doctors on Sept. 22 that using acetaminophen during pregnancy may come with an increased risk of neurological conditions.

The FDA said it was also requiring an update label for acetaminophen, which will include the information about a link between the drug and autism.

The move comes after U.S. health officials said several studies have found that acetaminophen use during pregnancy can increase the risk of autism, including a review of 46 prior studies published in August.

One of the researchers of that study, Diddier Prada of the Icahn School of Medicine at Mount Sinai, said they found that higher-quality studies “are more likely to show a link between prenatal acetaminophen exposure and increased risks of autism and ADHD.”

Health Canada said it still recommends acetaminophen as a pain or fever treatment for pregnant women, adding that the medication has been “used safely by millions of Canadians for decades,” including during pregnancy and while breastfeeding.

It advised patients to use the “lowest effective dose” for the “shortest duration.”

The organization said that untreated fever and pain for a pregnant woman can cause risks to the unborn child.

Pregnant women who have concerns are advised to talk to their health care provider, it said.

Health Canada said it monitors the safety of all authorized medicines and if new scientific evidence demonstrated a risk, it would take action to update labels, inform health care professionals, and provide advice to Canadians.

A spokesperson for Tylenol’s parent company, Kenvue, previously told The Epoch Times in an email that they disagreed with the FDA’s position.

“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers,” it said.

Zachary Stieber contributed to this report.