FDA Addresses Acetaminophen and Autism Risks

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

and use of acetaminophen for fevers and pain in pregnancy

by prescribing the lowest effective dose for the shortest

necessary du-duration, and only when treatment is

required.

Furthermore, thanks to 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 acetam-acetaminophen used by

young children, especially

since strong evidence also has associated it with liver

toxicity. Some studies have also found the 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 for--

to autism for pregnant women,

infants, and toddlers, our research has revealed that folate

deficiency

in a child's brain can lead to autism