FDA Will Issue Notice to Doctors Linking Acetaminophen Use During Pregnancy to Autism

A few weeks ago, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. vowed to find the cause of rising autism cases by this September.

Apparently, a possible cause is the use of the pain-reliever acetaminophen (the active ingredient in Tylenol). President Donald J. Trump and his team now indicate that the Food and Drug Administration (FDA) will issue a notice to doctors shortly that the use of Tylenol during pregnancy may be linked to an increased risk of autism.

In a press conference at the White House, President Donald Trump said the Food and Drug Administration will begin notifying physicians immediately that it is “strongly recommending that women limit Tylenol use during pregnancy unless medically necessary.””They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” Trump said. “That’s, for instance, in cases of extremely high fever.”Studies on this question have not shown a direct cause and effect. Some studies point to a possible link, but major medical groups have evaluated the evidence and continue to recommend acetaminophen as the safest painkiller during pregnancy.

The press has been quick to dismiss the potential links by citing “experts” and their claims that acetaminophen is the safest pain reliever to use in pregnancy. A review of the headlines offered by the elite press claims there are “unproven links,” “decades of evidence,” and “claims not backed by science.”

Reuters went so far as to quote the maker of Tylenol, assuring everyone that it was safe to use during pregnancy.

“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,” Kenvue, the maker of Tylenol, said in a statement ahead of the announcement.Shares of Kenvue (KVUE.N), opens new tab slid more than 7% during Monday’s stock market session as investors braced for Trump’s announcement. But the shares recovered 5% in extended trade.

The mainstream press and the Big Pharma advocates in the media and government are about to get a lesson on how meaningless their claims are in the post-COVID era.

Let’s review some of the “mixed” findings for a few moments, which seem to indicate there is a potential for a link.

To begin with, a major systematic review led by Harvard T.H. Chan School of Public Health and the Icahn School of Medicine at Mount Sinai analyzed 46 studies, finding that 27 studies reported significant links between prenatal acetaminophen exposure and neurodevelopmental disorders, including autism and ADHD. In contrast, nine found no link and four indicated protective effects. The review applied the Navigation Guide, a gold-standard methodology for environmental health research.

Results: We identified 46 studies for inclusion in our analysis. Of these, 27 studies reported positive associations (significant links to NDDs [neurodevelopment disorders]), 9 showed null associations (no significant link), and 4 indicated negative associations (protective effects). Higher-quality studies were more likely to show positive associations. Overall, the majority of the studies reported positive associations of prenatal acetaminophen use with ADHD [attention-deficit/hyperactivity disorder], ASD [autism spectrum disorder], or NDDs in offspring, with risk-of-bias and strength-of-evidence ratings informing the overall synthesis.Conclusions: Our analyses using the Navigation Guide thus support evidence consistent with an association between acetaminophen exposure during pregnancy and increased incidence of NDDs. Appropriate and immediate steps should be taken to advise pregnant women to limit acetaminophen consumption to protect their offspring’s neurodevelopment.

The authors called for caution and further research, recommending judicious use under medical supervision.

While the study does not show that acetaminophen directly causes neurodevelopmental disorders, the research team’s findings strengthen the evidence for a connection and raise concerns about current clinical practices.The researchers call for cautious, time-limited use of acetaminophen during pregnancy under medical supervision; updated clinical guidelines to better balance the benefits and risks; and further research to confirm these findings and identify safer alternatives for managing pain and fever in expectant mothers.“Pregnant women should not stop taking medication without consulting their doctors,” Dr. Prada emphasized. “Untreated pain or fever can also harm the baby. Our study highlights the importance of discussing the safest approach with health care providers and considering non-drug options whenever possible.”

This review, published in August of this year, clearly supports the direction the FDA is headed: ensuring that both doctors and their potential patients are well-informed about the data and fully aware of the implications when making drug-use decisions.

Or, are we not to believe the experts at the Harvard School of Public Health or Mt. Sinai simply because the maker of Tylenol says it’s safe to use during pregnancy?

The anti-Trump, anti-RFK, GOP-hate antics of the press are hurting our country in countless ways. Failure to present all the information, including the recent findings from obviously credible scientists, means that expectant mothers are not getting complete information based on high-quality analysis. The news coverage on this announcement provides even more reasons to distrust our press, and we already had plenty based on its shameful coverage of the COVID-19 pandemic.

I will simply note that this new study probably managed to finally see the light of day because silencing data counter to preferred Big Pharma narratives is no longer occurring.

Tags: Health and Human Services (HHS), Medicine, Robert F. Kennedy Jr., Science, Trump Administration

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