The CEO and director of the pharmaceutical Kenvue, manufacturer of the Tylenol analgesic, met privately this week with the Secretary of the Department of Health and Human Services of the United States (HHS), Robert F. Kennedy Jr., to try to dissuade him to include the medicine as a possible cause of autism in an upcoming report, according to The Wall Street Journal.
HHS officials announced that the department is carrying out a study on the causes of autism, and recent reports suggest that HHS will publish an analysis that relates the advancement of autism to the use of Tylenol by the mother during pregnancy, among other possible causes. The report is expected to be published this month.
Tylenol is the commercial name of the paracetamol analgesic.
The American College of Obstetricians and Gynecologists has said that there is no evidence of a causal link between the use of Tylenol during pregnancy and the diagnosis of autism in children.
In a statement made this Friday, an HHS spokesman said that officials usually meet with interested parties to know their views.
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Kenvue Responds to Concerns Over Paracetamol Use During Pregnancy
September 13, 2025 – Kenvue, the company that markets Tylenol (paracetamol), has issued a statement addressing recent concerns regarding the safety of paracetamol consumption during pregnancy. The statement comes amid renewed discussion following research suggesting a potential link between paracetamol use in pregnancy and neurodevelopmental issues in children.
Kenvue stated it would cooperate fully with any inquiries from regulatory bodies. The company emphasized its commitment to consumer safety and highlighted the ongoing review of scientific evidence by agencies like the U.S. Food and Drug Governance (FDA).
“We are concerned about the possible confusion and misinformation of consumers about the security of paracetamol consumption during pregnancy, especially now that the cold, flu and cough season is approaching,” the company said in a statement. “We call the regulatory agencies to continue to objectively review the scientific evidence on this issue, as they have done for many years. The FDA has been studying this issue for more than a decade and has made multiple revisions since 2014, and continues to recommend paracetamol during pregnancy and maintaining the same labeling requirements.”
Kenvue also reiterated the recommendation, already present on product labels, that pregnant women consult their healthcare provider before taking any over-the-counter medication, including paracetamol.
The debate centers around recent studies suggesting a possible association between paracetamol exposure in utero and an increased risk of neurodevelopmental problems, such as attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder. However, establishing a direct causal link remains challenging.
Dr. Christopher Zahn, head of clinical practice at the American College of Obstetricians and Gynecologists (ACOG), affirmed that “There is no clear evidence that demonstrates a direct relationship between the prudent use of paracetamol during pregnancy and fetal development problems.” He further explained that neurological development disorders are often multifactorial and arduous to attribute to a single cause. “Pregnant patients should not be scared and stop taking advantage of the numerous benefits of paracetamol, which is safe and one of the few options that pregnant people have to relieve pain.”
Tylenol remains a widely used pain reliever in the United States, and the FDA currently recommends it as a safe option during pregnancy. The FDA advises against the use of non-steroidal anti-inflammatory drugs (NSAIDs) from 20 weeks of gestation due to their potential to reduce amniotic fluid levels. https://www.fda.gov/drugs/pregnancy-breastfeeding-and-medicine/pain-and-fever-during-pregnancy
The FDA continues to monitor emerging research on paracetamol and pregnancy and will update its recommendations as needed.