The Safety of Acetaminophen in Pregnancy and Leucovorin Research

Headlines in recent weeks suggested links between acetaminophen (Tylenol) use and autism, as well as information about leucovorin as a suggested treatment for autism. These stories can generate great interest, concern, and questions from families.

Autism is a complex neurodevelopmental condition, and it’s more important than ever that as healthcare providers, we are thoughtful and consistent in our professional conversations and support of families. This article shares resources to support evidence-based conversations with patients and families.

In line with the professional consensus of leading medical organizations, Seattle Children’s is sharing the following with families:

• Acetaminophen use during pregnancy is not clearly associated with an increased risk of autism in rigorous, well-controlled studies. Acetaminophen remains an important, safe and effective treatment for some medical issues, such as fever, in pregnancy.
• It is critically important that expectant parents talk with their healthcare provider about what is best for their health during pregnancy, particularly when managing important medical issues, such as fever, which can be harmful if untreated.
• Leucovorin has recently been FDA-approved for the treatment of cerebral folate deficiency, an extremely rare and specific neurological condition that may present with features of autism. At this time, leucovorin is not an established or universally recommended treatment for autism. Studies are ongoing, and more research is needed before conclusions can be drawn or clinical guidelines changed. Seattle Children’s Autism Center will continue to investigate this intervention in conjunction with our colleagues over the next year. We do not anticipate wide-spread recommendations for testing and treatment until further research is available.

For additional support, feel free to reference these talking points Seattle Children’s teams are using when speaking with families.

Does taking acetaminophen (Tylenol) during pregnancy cause autism or other neurological conditions?

• Experts at the American College of Obstetricians and Gynecologists (ACOG) recommend acetaminophen (Tylenol) as an important, safe and effective treatment for some medical issues during pregnancy, such as fever. Fever can be harmful to you and your baby if it is not treated.
• In rigorous, high-quality studies, taking acetaminophen during pregnancy is not clearly associated with an increased risk of autism.
• Research over the past several decades suggests that, rather than there being a single cause for autism, it has many complex causes, including genetic ones.
• It is important to talk with your healthcare provider about what is best for your health during your pregnancy.

Is it safe to give my child acetaminophen (Tylenol)?

• The American Academy of Pediatrics (AAP) recommends acetaminophen (Tylenol) as a safe and effective treatment for some conditions, including fever, in children.
• If you have questions or concerns, check with your child’s pediatrician or healthcare provider before giving any type of medicine to your child.

What is leucovorin?

• Leucovorin is a form of folinic acid/vitamin B9.
• Leucovorin calcium tablets have recently been approved by the FDA for patients with cerebral folate deficiency (CFD), an extremely rare neurological condition. People with CFD may have symptoms such as developmental delays or autism.

Could my child’s autism be treated with leucovorin?

• At this time, leucovorin is not an established or universally recommended treatment for autism.
• According to experts at the American Psychiatric Association (APA), many more years of research are needed before we will know if leucovorin is an appropriate treatment for some individuals with autism when speaking with families.

Seattle Children’s continues to follow the guidelines and recommendations of leading medical organizations including the American Academy of Pediatrics (AAP), the American Psychiatric Association (APA) and the Society for Developmental and Behavioral Pediatrics (SDBP).

Seattle Children’s is proud to partner closely with community healthcare providers to ensure the safety and well-being of our region’s patients and families. By working together, sharing the latest research, and following evidence-based guidelines, we strive to provide consistent, trustworthy care and clear information.

For more information:

• Read through these FAQs about Acetaminophen in Pregnancy | ACOG (American College of Obstetricians & Gynecologists).
• Review this statement from the American Academy of Pediatrics (AAP) on the recent headlines.
• Read this statement from the Society for Developmental and Behavioral Pediatrics On Recent Autism Claims that shares helpful information about acetaminophen and leucovorin.
• Share the Making Sense of Recent Autism News: What Families Should Know (PDF) handout with families.
• Refer to the American Psychiatric Association (APA) statement which emphasizes the need for evidence-based support.
• Read about the actions the Food & Drug Administration (FDA) is taking to make a treatment available for Autism symptoms.