By Dr. Avi Verma

This week, President Donald Trump stirred nationwide concern after declaring that the FDA would consider changing the safety label of acetaminophen (Tylenol), citing what he described as a “very increased risk of autism” when taken during pregnancy. His remarks instantly sparked alarm among expectant mothers and drew sharp criticism from leading medical organizations, public health experts, and pharmaceutical representatives who argue the claim is scientifically weak, medically irresponsible, and politically questionable.

The President’s statement and its fallout

Trump’s announcement relied heavily on a recent meta-analysis of 46 studies that reported an association between acetaminophen use in pregnancy and higher rates of autism spectrum disorder (ASD) and ADHD in children. However, association is not causation — a distinction many health experts were quick to underline. “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients,” the American College of Obstetricians and Gynecologists (ACOG) said in a strongly worded statement.

The FDA itself appeared to temper Trump’s claim, noting that while studies do show associations, other high-quality research — such as a 2024 Swedish sibling study — found no difference in autism or ADHD rates among children exposed in utero compared to their siblings who were not. The FDA emphasized: “To date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”

What the science actually says

Epidemiologists stress that the data is mixed and inconclusive. Brian Lee, PhD, an epidemiologist at Drexel University, explained the problem with Trump’s framing: “Eating ice cream is associated with drowning, but it’s not causal. Hot weather causes both. That’s what we’re likely seeing here — confounding factors, not direct causation.”

Many researchers believe that autism is the result of complex genetic-environmental interactions, not a single exposure like Tylenol. Current evidence does not support a causal link. On the contrary, the risks of not treating fever or pain during pregnancy are well established — ranging from preterm birth to birth defects and maternal complications like hypertension or depression.

Why Tylenol is still considered the safest option

For decades, acetaminophen has been the preferred pain reliever during pregnancy. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or aspirin are known to cause kidney problems in unborn babies after 20 weeks and can reduce amniotic fluid levels. This is why the FDA and ACOG continue to recommend acetaminophen as the safest over-the-counter choice — when used at the lowest effective dose and under a physician’s supervision.

Dr. Judette Louis of the Society for Maternal-Fetal Medicine noted: “Most people in pregnancy use Tylenol for brief periods of time to address acute illness. The administration’s advice to limit dosage and duration isn’t new — it’s what we already recommend.”

Political motivations or a genuine health concern?

Critics argue that Trump’s announcement reflects a recurring theme in his political style: raising alarm on health issues without fully weighing the scientific evidence. By placing autism at the center of the conversation, the President reactivated a long-standing controversy that has previously fueled misinformation campaigns — from the debunked vaccine-autism myth to unverified claims about chemicals in food.

Some political analysts suggest that Trump’s framing may appeal to certain voter blocs skeptical of mainstream medicine, echoing his past approach during the COVID-19 pandemic when he promoted unproven treatments. Others argue it reflects an attempt to pressure the FDA into a tougher regulatory stance as part of his “America First” healthcare message.

Label change process: A long road ahead

Even if the FDA were to act, the process of updating Tylenol’s safety label could take months, if not years. The agency would need to formally notify the drug manufacturer, review data, and debate wording. Johnson & Johnson, Tylenol’s producer, has already pushed back, stressing that “Tylenol is one of the most studied medications in history — and is safe when used as directed by expecting mothers, infants, and children.”

The real risk: Panic and misinformation

Medical professionals worry that the biggest consequence of Trump’s remarks will be unnecessary fear among pregnant women. Dr. Louis warned: “Untreated fever and pain during pregnancy carry significant maternal and infant health risks. Patients should not stop taking acetaminophen out of fear but should always consult their doctor.”

The Society for Maternal-Fetal Medicine echoed this, noting that most pregnant women who use Tylenol deliver healthy babies. “The most well-established risk factor for autism and neurodevelopmental disabilities is family inheritance, not acetaminophen use,” their statement concluded.

A critical balancing act

The controversy underscores the delicate balance between public health caution and political communication. While ongoing research into acetaminophen is valid and important, overstating findings risks fueling misinformation and undermining trust in healthcare providers. For expectant mothers, the guidance remains unchanged: consult your physician, use the lowest effective dose for the shortest duration, and don’t let politics dictate your health decisions.

Disclaimer

This article is intended for informational and analytical purposes only. It does not provide medical advice and should not be used as a substitute for professional healthcare consultation. Expectant mothers and patients should always seek guidance from their physician before making any decisions about medication use during pregnancy.