FDA to warn doctors about Tylenol-Autism link, sparking medical backlash

President Trump just made a public announcement that the active ingredient in Tylenol could be associated with an increased risk of autism, and he urged women not to take the drug during pregnancy.

Scientists and researchers are highly skeptical of the claim, arguing previous studies have been inconclusive.

Big picture view:

The Food and Drug Administration (FDA) will begin notifying doctors to warn pregnant patients about the potential risk. Many medical associations and groups are pushing back, calling the President’s claim of Tylenol as the cause of the increase in autism diagnoses irresponsible. 

Manufacturers will also update the warning labels on drugs like Tylenol. 

"Which is basically known as Tylenol during pregnancy, can be associated with a very increased risk of autism," said Trump. 

President Donald Trump says the number of autism diagnoses has risen dramatically in the last decade and the Food and Drug Administration will immediately instruct doctors to warn their pregnant patients about the risk.

"Since 2000 Autism has surged more than 400 percent," said Trump.

"I mean, there's a rumor, and I don't know if it's so or not…"

What they're saying:

The president and his medical leaders came to this conclusion in part from the opinion of Doctor Andrea Baccarelli, the Dean of the Harvard University Medical School, who reviewed 46 worldwide human studies.

"So, taking Tylenol is uh...not good. I'll say it is not good," said President Trump.

Medical experts also took issue with the way the major health announcement was rolled out. The president at times acknowledged some information might not be correct or a rumor.

"Is that a correct statement by the way?" asked Trump.

"I mean, there's a rumor, and I don't know if it's so or not, that Cuba, they don't have Tylenol because they don't have the money for Tylenol, and they have virtually no autism."

The scientific consensus

The other side:

The makers of Tylenol, whose main ingredient is acetaminophen, pushed back against the White House, writing in a statement:

"We believe independent, sound science clearly shows that taking acetaminophen does not cause autism," said a Kenvue spokesperson.

Drexel University professor, Brian Lee, co-authored the largest study on this topic, with 2.5 million children in Sweden being followed for 20 years.

"Our professional opinion is that there is no strong evidence to support that acetaminophen during pregnancy causes autism, ADHD or any other neurodevelopmental disorder," said Lee.

Including siblings where one was exposed to acetaminophen and one was not. His research points to other factors.

"And so these other factors could be, for example, infection during pregnancy, which has been linked to autism, and also you know whether or not a mom takes acetaminophen, the same thing for a fever as well, and then finally the elephant in the room when it comes to neurodevelopmental disorders is heritability," said Lee.

Genetic disorders that could be passed from parents to baby.

Beyond Acetaminophen: Other suspected links

Dig deeper:

Robert F. Kennedy Jr, the secretary of Health and Human Services, also shared that there is an alleged link between folinic acid deficiency and those diagnosed with autism, and potential treatment with a drug called leucovorin. 

"Peer-reviewed literature has documented that up to 60 percent of children with a folinic deficiency that have ASD can have improved verbal communication if given Leucovorin." 

The American Psychiatric Association did not go that far. In a statement, the APA states, "It will require many more years of research before we know if leucovorin is an appropriate treatment for individuals with autism." 

President Trump also touched on what he called a potential connection between vaccines and autism. The president encouraged parents to space them out for children. 

However, the American Psychiatric Association stated that claims of vaccines causing autism have been repeatedly discredited in peer-reviewed studies. 

What Local Doctors Are Saying

Local perspective:

"The way I look at it, don't take it, there's no downside in not taking it," said Trump.

There is a downside, as acetaminophen-Tylenol is the only drug approved for use during pregnancy.

Ob-gyn Wendy Parnell says she agrees with the findings in that Swedish study where 2.5 million kids were studied for 20 years.

Parnell says there are likely multiple contributing factors beyond one exposure. She says you can’t link one medication to an autism diagnosis.