Following recent federal announcements regarding autism spectrum disorder (ASD), including statements about acetaminophen (e.g., Tylenol) and leucovorin treatment, Vanderbilt University Medical Center wants to provide the following information and resources for providers, patients and families. At VUMC, providing high-quality, evidence-based care is a core value. We believe all autistic children have value and remain committed to delivering care that reflects the best available science.
VUMC acknowledges that ASD represents a complex neurodevelopmental spectrum that includes people with many different levels of support needs and identity. Our dedicated team of expert medical providers, behavioral professionals, and support staff are committed to providing excellent, person-centered care to promote patient health and well-being.
FAQs for providers regarding ASD, acetaminophen and leucovorin
FAQs for parents and families regarding ASD, acetaminophen and leucovorin
FAQs for providers regarding ASD, acetaminophen (e.g., Tylenol) and leucovorin
Although there have been new federal announcements — including FDA label updates for leucovorin and proposed safety label changes for acetaminophen — VUMC has not changed its clinical care protocols at this time. We continue to follow rigorous medical standards and carefully review new scientific information and guidance as it becomes available.
Is acetaminophen (e.g., Tylenol) now considered unsafe for pregnant individuals or children?
The FDA announced plans to update safety labeling for acetaminophen based on a potential association link between its use during pregnancy and neurodevelopmental outcomes like autism. When used during appropriate intervals and at appropriate dosages, acetaminophen remains widely regarded as safe for both pregnant women and children. VUMC encourages patients to talk with their health care providers about appropriate usage for both pregnant women and children.
What do we know about folate, folate receptor autoantibodies, and leucovorin treatments?
Getting enough folate during pregnancy is important for fetal and infant health. All pregnant women are already advised to take folate. More research is needed to understand whether folate relates to autism development or is an effective treatment for some autistic people. Existing research on using folate receptor tests or leucovorin treatment for ASD is very limited and requires more investigation. It is currently unknown if available folate receptor tests and treatments like leucovorin are reliable or helpful for ASD at this time.
Where can I learn more about recent announcements, find data about trials, and view practice recommendations/statements?
Given the importance of providing clear and accurate information, the Department of Health and Human Services and several leading professional organizations have issued updated statements that may provide clarification to your questions/concerns:
The Society for Developmental and Behavioral Pediatrics has provided two statements regarding leucovorin, acetaminophen and autism for health care professionals and families:
The American Academy of Pediatrics has provided an updated statement regarding vaccine safety and effectiveness.
The American College of Obstetricians and Gynecologists has provided an updated statement regarding the safety and benefits of acetaminophen during pregnancy.
The Department of Health and Human Services has provided an updated Autism Fact Sheet regarding current evidence regarding the safety of acetaminophen and leucovorin treatment.
FAQs for parents and families regarding ASD, acetaminophen (e.g., Tylenol) and leucovorin
Vanderbilt University Medical Center wants to provide information about the safety of acetaminophen (e.g., Tylenol) and using leucovorin to treat autism spectrum disorder (ASD). While there have been new federal announcements, VUMC has not changed its recommendations or clinical care protocols. VUMC’s decisions are based on providing high-quality, evidence-based care to all patients. Below are answers to recent questions about acetaminophen and leucovorin.
Is acetaminophen (e.g., Tylenol) now considered unsafe for pregnant individuals or children?
When used short-term and at appropriate dosages, acetaminophen is safe during pregnancy and for children. VUMC encourages patients to talk to their health care providers about when and how to use acetaminophen for pregnant women and children.
What do we know about folate, folate receptor autoantibodies, and leucovorin?
Getting enough folate during pregnancy is important for fetal and infant health. All pregnant women are already advised to take folate.
At this time, there is not enough research to say an autistic person should take leucovorin or have a folate receptor test. The current research is very limited. More research is needed to determine if testing for folate receptors or taking leucovorin is reliable or helpful.
Where can I learn more about recent announcements and questions I have about my child?
Please talk with your health care providers with any questions or concerns. There is also information from the Department of Health and Human Services and several professional organizations about these topics. Please go to the links below for more information.
The Society for Developmental and Behavioral Pediatrics has provided two statements regarding leucovorin, acetaminophen, and autism for health care professionals and families:
The Department of Health and Human Services has provided an updated Autism Fact Sheet regarding current evidence regarding the safety of acetaminophen and leucovorin treatment.
The American Academy of Pediatrics has provided an updated statement regarding vaccine safety and effectiveness.
The American College of Obstetricians and Gynecologists has provided an updated statement regarding the safety and benefits of acetaminophen during pregnancy.
