Trump links autism to acetaminophen use during pregnancy: Your Tylenol questions answered

Earlier this week, President Donald Trump and Health and Human Services Director Robert F. Kennedy announced that taking Tylenol during pregnancy can lead to an increased risk of autism for unborn babies due to the drug's active ingredient acetaminophen. 

Since the announcement, major medical organizations and scientific groups are reacting to the assertion, saying that there's limited evidence to suggest the association.

FOX 35 News Reporter Marie Edinger decided to take a deeper look into Tylenol. Here's what she found. 

Trump links autism to acetaminophen use during pregnancy

The backstory:

You’ve probably heard a lot of talk about Tylenol in the past couple days. 

Earlier this week, Trump and Kennedy held a news conference where the president told the public, "With Tylenol, don’t take it. Don’t take it." They said the use of Tylenol during pregnancy can be associated with a "very increased risk of autism."

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The conversation is actually about the generic name of Tylenol, acetaminophen. This is an active ingredient you’ll also find in Dayquil, Mucinex, Midol, Sudafed and tons of other medications.

The Science:

Trump and Kennedy are not referring to a single specific study. Rather, they’re citing reviews of a group of 46 studies. Some of those reviewers suggested acetaminophen could be linked to autism and ADHD.

The United States Food and Drug Administration (FDA) explained in a letter to physicians Monday, "While an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established, and there are contrary studies in the scientific literature."

However, this is very different from the firm language Trump used: "Taking Tylenol is not good."

Dr. Alycia Halladay, the chief science officer with the Autism Science Foundation, emphasized the difference between a link and a cause.

"You can take two random things and link them together and show an association," she said, "But the strength of evidence to have something be a cause is much higher."

Kennedy also talked this week about a drug he says can treat autism.

It’s a cancer drug called Leukovorin, which has actually been around for a while. The FDA has only approved it for cerebral foliate deficiency, a very rare condition that affects a limited number of people with autism.

"Autism is such a diverse and complex condition that there's not going to be a single treatment that's going to help all people with autism," Halladay said. 

Questions remain after Trump's announcement

What we don't know:

The studies Trump and Kennedy referenced in the announcement don’t say how much acetaminophen the women took, how often they took it or in what trimester the acetaminophen has the potential for the most impact.

The reviews also don’t explain why the women took acetaminophen, leaving the question open of whether the condition they took it for in the first place could have been linked to autism or ADHD rather than the medication they used to ease symptoms of that condition.

Genetic influences and certain environmental factors have been proven through replicated research as causes of autism.

What are the risks of taking Tylenol?

Dig deeper:

Doctors worldwide, including family medicine physician Dr. Michael Sparks, tells pregnant women to take acetaminophen for pain and high fever.

"If the patient has a massive fever, we know that that causes direct harm to a growing fetus," Sparks said. "And, in that case, we definitely have to weigh those risks versus benefits. Doing nothing, avoiding Tylenol in that situation, is dangerous."

The FDA told physicians to recommend acetaminophen only sparingly. That’s been the standard practice already to use the smallest dose, for the shortest amount of time.

The experts who FOX 35 News spoke with said you should consult with your doctor about what’s right for you.

The FDA says there are other medications commonly used to treat the same things as acetaminophen, such as NSAIDs like aspirin, ibuprofen and naproxen (brands like Motrin, Aleve and Advil), which have been proven to have negative impacts on fetuses. There are even warnings on the labels for those medications.

The FDA said this week, "Acetaminophen is the safest over-the-counter alternative in pregnancy."

"Part of the concern that we have as physicians as well is, what is that going to make folks do?" Sparks asked. "What else are they going to grab for over the counter instead?"

What are Tylenol producers saying?

What they're saying:

Kenvue, the company that owns Tylenol, sent FOX 35 News a statement, which is copied below in full:

"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 about the health risks and confusion this poses for expecting mothers and parents. Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives. High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated. 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. The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism. We stand with the many public health and medical professionals who have reviewed this science and agree. We will continue to reinforce that expecting mothers speak to their health professionals before taking any over-the-counter medication and will explore all options to protect the health interests of American women and children."

The Source: This story was written based on information gathered by FOX 35 News Reporter Marie Edinger, who reviewed news conferences hosted by President Donald Trump and Health and Human Services Director Robert F. Kennedy. She also reviewed guidance released from the Food and Drug Administration following those conferences, and requested an interview, which was denied. Edinger then communicated with Kenvue, the company that produces Tylenol. Edinger spoke with three doctors in total for this story — a family medicine physician and an obstetrician, as well as the chief science officer for the Autism Science Foundation, who has a Ph.D. in biopsychology, and did her postdoctoral fellowship in pharmacology and toxicology. Edinger coordinated with the Consumer Health Products Association and reviewed their statement on acetaminophen. Edinger also reached out to every member of the Florida House of Representatives who serves in Central Florida and sits on the Health and Human Services Committee. She reached out to the Orange County Health Department and Florida Department of Health for health, but did not receive information from them.

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