CMS head Oz urges acetaminophen for fevers in pregnancy as FDA flags association; FDA to review leucovorin
CMS chief Dr. Mehmet Oz told CBS News pregnant women should take acetaminophen when clinically recommended, stressing that fevers can harm fetal development even as the White House and FDA flagged a possible association between prenatal acetaminophen and autism. Experts, ACOG and Tylenol maker Kenvue said the link is unproven and warned against abandoning fever treatment or switching to riskier drugs, while the administration’s promotion of leucovorin as a potential autism therapy has drawn scrutiny and calls for further scientific and regulatory review.
📊 Analysis & Commentary (1)
"The piece criticizes recent high‑profile alarm about acetaminophen in pregnancy (and the FDA's cautious messaging after political commentary), arguing the evidence is weak, that scaring people away from Tylenol risks greater harm from untreated fevers, and that policy and public messaging should remain evidence‑driven rather than politicized."
📰 Sources (10)
- Dr. Mehmet Oz, as CMS Administrator, told CBS News that pregnant women should take acetaminophen when recommended by a doctor and emphasized fevers pose risks in pregnancy.
- Oz cautioned against casual use for low‑grade aches and said he and other researchers found 'clues' pointing to leucovorin as a possible autism treatment; when asked, trial doctors said they would give leucovorin to their own child.
- The article quotes ACOG president Dr. Steven Fleischman reiterating that existing evidence does not show causation between acetaminophen and autism and urging use for fevers.
- Kenvue (Tylenol maker) issued a formal statement in the piece repeating that independent science shows acetaminophen does not cause autism.
- PBS NewsHour aired an on‑camera interview with Dr. Linda Eckert (Univ. of Washington) directly disputing the administration's claims linking acetaminophen to autism.
- The segment provides attributable expert commentary explaining the scientific uncertainty and clinical context (risks of untreated fever versus unproven associations).
- FDA Commissioner Marty Makary released an open letter to physicians advising clinicians to 'consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers.'
- Named medical officials (Dr. Steven Fleischman of ACOG and other clinicians) explicitly warned that letting fevers go untreated in pregnancy can cause cardiac and neurologic birth defects and that 'tough it out' messaging is dangerous.
- Medical experts warned patients may turn to alternatives (e.g., ibuprofen or aspirin) that carry known pregnancy risks, emphasizing acetaminophen remains the safest antipyretic/analgesic option in many cases.
- Clinicians report a spike in calls from patients to doctors' offices seeking guidance after the president's statement on acetaminophen and autism.
- The maker/owner of Tylenol publicly pushed back on President Trump's claim, per the CBS report.
- CBS observed doctors actively guiding patients in clinical offices in direct response to the announcement (practical, on-the-ground impact).
- Provides expert commentary from Dr. Steven Quay and Dr. Aggie Papazyan interpreting rising autism prevalence
- Summarizes CDC prevalence milestones with specific ratios for 1970s, 2000, 2010 and 2022 (up to 1 in 31)
- Notes global variation in prevalence and frames reasons (awareness, diagnostic criteria, earlier intervention) while acknowledging possible environmental contributions
- Kenvue issued a statement saying it 'strongly disagrees' with Trump's suggestion and that 'sound science clearly shows that taking acetaminophen does not cause autism.'
- Kenvue cited scientific reviews by multiple government regulators worldwide, including prior FDA reviews.
- Kenvue Inc. shares fell 7.5% on Monday, reducing market value by about $2.6 billion.
- AP reports the White House announcement promoted unproven ties between Tylenol, vaccines and autism without offering new evidence.
- ACOG president Dr. Steven Fleischman formally labeled Trump’s acetaminophen–autism remarks 'irresponsible' in a statement Monday.
- Fleischman said HHS’s announcement is 'not backed by the full body of scientific evidence' and is 'highly unsettling' without 'reliable data.'
- Confirms Trump said FDA will notify doctors that acetaminophen use in pregnancy 'can be associated' with increased autism risk.
- President Trump, speaking at the White House on Sept. 22, said women should not take acetaminophen 'during the entire pregnancy.'
- He also raised concerns about vaccines during the remarks, which experts described as unfounded.
- AP/PBS emphasize that a causal link between prenatal acetaminophen use and autism is unproven, citing decades of research attributing rising autism diagnoses largely to broadened definitions and awareness.
- Context: The push comes amid pressure from HHS Secretary Robert F. Kennedy Jr.’s movement, and follows recent ACIP changes to vaccine guidance.
- White House press secretary Karoline Leavitt will brief at 1 p.m. ET; Trump’s autism announcement event is scheduled for 4 p.m. ET today.
- Trump said at a Sunday memorial, 'I think we found an answer to autism,' and on the flight back suggested children receive too many vaccines, saying, 'It’s like you’re shooting up a horse.'
- Article notes HHS Secretary Robert F. Kennedy Jr. had promised earlier this year to determine the cause of autism by September.
- Trump to reporters Sunday: 'We're going to do it tomorrow' regarding the autism announcement
- WaPo/WSJ: plan ties autism to acetaminophen and promotes leucovorin for some autism symptoms
- Kenvue statement: 'Independent, sound science clearly shows acetaminophen does not cause autism'
- ACOG: 'No clear evidence' linking prudent prenatal acetaminophen use to fetal developmental issues
- Sweden cohort (~2.5M children, 25 years): no increased risk of autism, ADHD, or intellectual disabilities with prenatal acetaminophen