News
Article
Author(s):
Reproductive psychiatrist Sarah Oreck, MD, MS challenges the FDA's claims linking acetaminophen use in pregnancy to autism and ADHD, advocating for informed maternal care.
CLINICAL CONVERSATIONS
On September 22, the US Food and Drug Administration (FDA) announced a label change for acetaminophen (Tylenol and similar products) that reflect supposed evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and attention-deficit/hyperactivity disorder (ADHD) in children.1 In response to this announcement, Psychiatric Times connected with a reproductive psychiatrist and expert, Sarah Oreck, MD, MS, to discuss these claims.
Psychiatric Times: The FDA has issued a statement that acetaminophen use during pregnancy causes neurological conditions like autism and ADHD in children. Can you share your thoughts on this announcement or provide any helpful data?
Sarah Oreck, MD, MS: Let me be crystal clear: this statement is simply not true. A February 2024 meta-analysis showed that acetaminophen use during pregnancy does NOT increase ADHD or autism risk.2 The earlier studies suggesting a link? Poor quality research that never should have made headlines.
People take acetaminophen for fevers, chronic pain, migraines—conditions that themselves could impact fetal development. You cannot separate these factors. It is like blaming umbrellas for rain—the research shows correlation, not causation. Acetaminophen remains one of the safest pain relief options in pregnancy when used appropriately and the evidence supports its use.
PT: Do you believe this announcement increases stigma surrounding autism and other such disorders?
Oreck: This narrative is deeply problematic, and frankly, infuriating. This is not about protecting children—it is about finding someone to blame while pathologizing autism as something that needs to be eradicated or cured. The premise that autism is something to prevent or eliminate is fundamentally flawed. Individuals with autism have made extraordinary contributions to science, technology, art, and every field imaginable. We are talking about neurodivergence, not a disease to be wiped out. Many autistic adults advocate powerfully for acceptance and accommodation, not cure.
Here is what is actually happening: while we shame pregnant people over acetaminophen, children with autism are waiting months for essential services. Families are bankrupting themselves to access therapies. Schools lack basic resources for neurodivergent students. The real scandal is not Tylenol, it is our fundamentally broken support system. If this administration truly cared about outcomes for children with autism, we would invest in early intervention programs, educational support, and family resources. Instead, we are creating fear around one of the few safe medications available during pregnancy. That is not science-based medicine; it is scapegoating.
PT: How does medical mistrust put mothers in particular at risk? What impact will news like this announcement have on maternal mental health as a whole?
Oreck: The message is always the same: your pain does not count. Maternal suffering does not matter, just endure for the baby. Medical mistrust is already a crisis for mothers, but misinformation like this will cause real harm. Pregnant people will endure dangerous fevers because they are terrified, which, untreated, can cause neural tube defects, among other avoidable outcomes. These are real, immediate risks, not theoretical ones from flawed research.
PT: What advice can mental health clinicians offer mothers who are afraid? How can mental health clinicians combat misinformation or reduce fear in patients?
Oreck:Validate their fear—it is understandable given the irresponsible reporting. Then walk them through the actual science and remind them: correlation does not equal causation. We will never have perfect data on pregnancy medications because we cannot ethically run controlled trials on pregnant people. If you took Tylenol for fever, you protected your pregnancy. If you took it for pain, you took care of yourself so you could take care of your baby. The risk of untreated conditions is often far greater than theoretical medication risks. Maternal suffering is not a virtue. You made the best decision with the information available. Your child's outcomes are not a referendum on your worth as a parent.
PT: Anything else you would like to share?
Oreck:This is medical gaslighting on a massive scale. At Mavida Health, we do things differently. We believe our patients when they tell us something is wrong. We do not dismiss maternal pain as "just hormones" or say "you seem fine" when you are struggling. Evidence-based care means trusting the research, but it also means trusting mothers to make informed decisions about their own bodies. That is the standard of care we should all be fighting for.
PT: Thank you!
Dr Oreck is a reproductive psychiatrist and therapist, as well as the cofounder of Mavida Health.
References
1. FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy. News release. September 22, 2025. Accessed October 1, 2025. https://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy
2. Ahlqvist VH, Sjöqvist H, Dalman C, et al. Acetaminophen use during pregnancy and children’s risk of autism, ADHD, and intellectual disability. JAMA. 2024;331(14):1205-1214.
Receive trusted psychiatric news, expert analysis, and clinical insights — subscribe today to support your practice and your patients.