HHS Ties Acetaminophen Use During Pregnancy to Autism, Despite Widely Conflicting Evidence

President Donald Trump on Monday afternoon announced that research completed by his administration had concluded that acetaminophen, marketed as Tylenol, is associated with some cases of autism. "Ideally, a woman wouldn't take Tylenol...unless medically necessary," Trump said during a press conference.

Referring to the over-the-counter fever reducer and analgesic as "no good," he added that pregnant women should "fight like hell" against using acetaminophen while pregnant unless a fever was extremely high and they couldn't "tough it out."

In a September 22 communication to clinicians, the FDA's language was more measured. The agency noted that accumulated evidence suggests the use of acetaminophen during pregnancy "may be associated with an increased risk" of neurologic conditions such as autism and attention deficit hyperactivity disorder."

The letter, over the signature of FDA Commissioner Marty Makary, MD, PhD, also advised that, while clinicians should consider minimizing use of the antipyretic and pain reliever for pregnant patients, that approach should be balanced "with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics." The letters states further:

"To be clear, 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. The association is an ongoing area of scientific debate and clinicians should be aware of the issue in their clinical decision-making, especially given that most short-term fevers in pregnant women and young children do not require medication."

Based on the "evidence of possible association between autism and acetaminophen use during pregnancy," the FDA on Monday initiated a safety label change for the OTC analgesic and will also launch a nationwide public service campaign "to inform families and protect public health," according to the agency press release. (letter)

Medical Societies Push Back

Professional organizations were swift to dispute the proposed link. The claim "is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children," noted American College of Obstetricians and Gynecologist (ACOG) president Steven Fleishman, MD, MBA, in a statement. The suggestion is “not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy,” he continued.

Further, Fleishman stressed that the conditions typically calling for use of acetaminophen during pregnancy "are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus." He adds that, naturally, use of any medication during pregnancy requires a careful consideration of the risks as well as the benefits.

The Society for Maternal and Fetal Medicine also continues to recommend acetaminophen during pregnancy. "Untreated fever, particularly in the first trimester, increases the risk of miscarriage, birth defects, and premature birth, and untreated pain can lead to maternal depression, anxiety, and high blood pressure," the society wrote in a statement on use of acetaminophen during pregnancy.

"At this time, the weight of scientific evidence that acetaminophen use during pregnancy causes an increased risk for autism or ADHD is simply inconclusive." Sindhu Srinivas, MD, MSCE, president of SMFM said in the statement. "Pregnant patients can be reassured that using acetaminophen to treat pain and fever is safe," she concluded.

“You are inducing tremendous guilt and tremendous anger on the part of women, both about a drug, about their doctors and about their own behavior,” Arthur Caplan, PhD, professor and founding head of the division of medical ethics at NYU Grossman School of Medicine," told Healio. “Many of the autism groups that I’m seeing online right now are saying they don’t see causation, but they are very worried about guilt.”

Echoing words from ACOG president Fleischman, Caplan called the announcement "premature and unethical" and worried about the impact on mothers of children with autism who used acetaminophen during pregnancy.

The American Psychiatric Association (APA) also issued a statement Monday criticizing the federal government for its statements on acetaminophen.

“Autism is a complex disorder, and it is incorrect to imply that a handful of studies have established causation,” association wrote. “ A strong base of evidence shows that acetaminophen, when taken as directed, is safe for use during pregnancy. Any decisions around a course of treatment should be determined by a patient and their doctor.”