Summary

The Food and Drug Administration (FDA) announced that it has “initiated the process for a label change for acetaminophen,” also known by the brand name Tylenol, because of claims that use during pregnancy may be associated with an increased risk of neurological conditions such as autism and ADHD in children. FDA has sent a “physician’s notice” to doctors across the country acknowledging that “a causal relationship has not been established” between acetaminophen and autism and that “there are contrary studies in the scientific literature.” Despite this caveat, FDA says “an association between acetaminophen and autism has been described in many studies” and that it is working on a change to the label, which refers to the written prescribing and safety information that comes with a medication. Secretary Kennedy also announced that HHS is launching a “nationwide public service campaign.” Kennedy’s announcement was made alongside President Trump who falsely claimed that evidence suggests acetaminophen use in pregnant women has a causal relationship with long-term neurological effects on their children. 

Acetaminophen

Acetaminophen is currently the only safe over-the-counter option for pain or fever for pregnant people and major medical groups have affirmed the safety of use during pregnancy. The American College of Obstetricians and Gynecologists (ACOG) called claims that acetaminophen use during pregnancy causes autism “highly concerning” and “irresponsible” and the American Academy of Pediatrics confirmed that “studies do not point to a causal link between the use of acetaminophen and autism in children or in pregnancy, and extensive research indicates there is no single root cause of autism.”