Trump Administration To Unveil Tylenol-Autism Review, Tout This Drug As Potential Treatment: Report – Kenvue (NYSE:KVUE), Pfizer (NYSE:PFE)

The Trump administration is expected to unveil new efforts on Monday examining whether one widely used drug may be linked to autism and whether another could help treat it, according to people familiar with the plans who spoke to The Washington Post on condition of anonymity because the announcement was not yet public.

Fed Officials Weigh Tylenol Guidance For Early Pregnancy

Federal health officials are expected to flag concerns about pregnant women’s use of acetaminophen, the active ingredient in Tylenol, after reviewing recent research, including an August review by Mount Sinai and Harvard, that suggests a possible association when taken early in pregnancy. The officials plan to advise against early use unless treating fever, the Post reported.

Major medical groups, including the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists, have long said acetaminophen remains appropriate for pregnancy when used as directed. A large 2024 peer-reviewed medical journal study by JAMA using sibling comparisons found no increased risk of autism or ADHD tied to prenatal use. Kenvue Inc. KVUE, which makes Tylenol, has defended the medicine’s safety.

Benzinga previously reported the administration’s direction and market fallout as Robert F Kennedy Jr. prepared a report and Kenvue pressed its case.

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Leucovorin Trials Stir Treatment Hopes

Separately, officials are poised to highlight leucovorin or folinic acid as a potential treatment. Early randomized, double-blind, placebo-controlled trials in children with autism reported improvements in speech and comprehension. FDA officials have reviewed potential labeling language, the Post said.

Those leucovorin findings have rippled through the scientific community, reigniting debate over autism’s causes. Some experts had viewed the condition as largely genetic and thus not readily treatable, while others note emerging evidence that biology and environment both play roles.

Donald Trump Prioritizes Autism Push

The push is a stated priority for President Donald Trump, who has frequently cited rising autism rates and previewed Monday’s event at a memorial for activist Charlie Kirk. The CDC now estimates autism affects about 1 in 31 U.S. 8-year-olds, up from roughly 1 in 150 in 2000.

The initiative involves Health and Human Services Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary and NIH Director Jay Bhattacharya and coincides with a new NIH autism data-science effort funding 13 teams.

Major companies that manufacture leucovorin in the U.S. market include Teva Pharmaceuticals Industries Ltd TEVA, Hikma Pharmaceuticals Plc and Meitheal Pharmaceuticals. Pfizer Inc. PFE also markets leucovorin.

Benzinga Edge Stock Ranking shows KVUE has a poor short, mid-term and long-term price trend. More detailed performance insights are available here.