FDA's Findings on Acetaminophen and Autism

important findings from our autism work

that are vital for parents to know

as they make these decisions.

First, HHS will act on acetaminophen.

The FDA is responding to clinical and laboratory studies

that suggest a potential association between acetaminophen used during pregnancy

and adverse neurodevelopmental outcomes, including later diagnosis for ADHD and autism.

Scientists have proposed biological mechanisms linking prenatal acetaminophen exposure

to altered brain development.

We have also evaluated the contrary studies

that show no association.

Today, the FDA will issue a physician's notice

about the risk of acetaminophen during pregnancy

and begin the process to initiate a safety label change.

HHS will launch a nationwide public service campaign

to inform families and protect public health.

FDA also recognized that acetaminophen is often the only

tool for fevers and pain in pregnancy,

as other alternatives have well-documented adverse effects.

HHS wants, therefore, to encourage clinicians to exercise their best judgment

in the use of acetaminophen for fevers and pain in pregnancy

by prescribing the lowest effective dose for the shortest necessary duration

and only when treatment is required.

Furthermore, thanks also to the politicization of science,

the safety of acetaminophen against the risk of neurodevelopmental disorders

in young children has never been validated.

Prudent medicine, therefore, suggests caution in acetaminophen use by young children,

especially since strong evidence also has associated it with liver toxicity.

Some studies have also found that use of acetaminophen

in children can potentially prolong viral illnesses.

FDA will drive new research to safeguard mothers,

children, and families.

In addition to a possible acetaminophen connection to autism for pregnant women,

infants, and toddlers, our research has revealed that

folate deficiency in a child's brain can lead to autism.