Texas has sued the makers of Tylenol, saying they misled pregnant women about possible neurodevelopmental risks. The case arrives as the U.S. Food and Drug Administration begins a label-change process and notifies physicians about studies that suggest an association. The American College of Obstetricians and Gynecologists responded on the same day, affirming acetaminophen’s role in pregnancy when used as directed. Therefore, families are now hearing starkly different claims and need a calm explanation. This article summarizes what changed in 2025, what the most cited studies actually show, how courts have viewed the evidence so far, and how to make practical decisions during pregnancy.
Texas Sues Tylenol Makers
On the 22nd of September, 2025, the FDA announced two actions. First, it initiated a process to update over-the-counter acetaminophen labeling. Second, it issued a physician notice summarizing the literature that describes an association between frequent or chronic prenatal use and neurodevelopmental outcomes. The agency stated that a causal relationship has not been established. The press announcement used careful language and reminded clinicians to weigh benefits and risks. The notice added that some signals appear stronger with chronic use across pregnancy. Therefore, the agency encouraged prudent prescribing while acknowledging ongoing uncertainty.
On the same day, ACOG reaffirmed its long-standing position. The organization wrote, “Acetaminophen remains the analgesic and antipyretic of choice during pregnancy,” while urging patients to use the lowest effective dose for the shortest necessary time and to speak with their obstetrician. ACOG also published a practice advisory that reviewed recent studies and emphasized the limits of observational designs. This alignment is important because the FDA and ACOG addressed different audiences yet delivered complementary messages. Labels inform purchasers, while practice advisories guide clinicians. Patients can reasonably expect both to evolve together as evidence changes.
In late October, Texas filed a separate state lawsuit against Johnson & Johnson and Kenvue. The complaint alleges deceptive marketing to pregnant women and raises questions about corporate transactions related to liability. Texas argues that companies minimized the potential risks. Kenvue counters that science does not support a causal link and warns that discouraging use could harm patients who need fever control. Readers should separate legal claims from medical guidance. Courts test whether marketing met legal standards. Clinicians weigh total risk in real pregnancies. Both arenas influence public debate; however, the clinical advice still follows evidence reviews.
What the Best Evidence Currently Says About Tylenol and Autism
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Most human studies on prenatal acetaminophen and autism or ADHD are observational. Researchers compare exposed and unexposed groups and then adjust for confounders. Some cohorts report higher odds of diagnoses or symptoms in exposed children. Others show attenuation after addressing unmeasured factors, including family traits and illness severity. A prominent 2021 consensus statement in Nature Reviews Endocrinology recommended caution with dose and duration. Yet a companion commentary explained that acetaminophen remains the safest available medicine for pain and fever in pregnancy, and that confounding by indication remains a serious concern. Therefore, the literature points to potential signals that deserve attention, but it does not prove causation.
Academic voices have also stressed uncertainty on the subject. In a 2025 Yale School of Public Health Q&A, epidemiologist Zeyan Liew said, “We do not know yet for sure whether acetaminophen causes autism.” He noted that associations appear in several studies, yet exposure misclassification and illness-related confounding can mislead. Yale’s research program has explored better exposure measures and sibling designs to test causal pathways. However, even improved designs cannot eliminate every bias. This is why regulators and professional groups both urge careful wording.
The FDA’s 2025 physician notice captures this balanced approach. It summarizes accumulating evidence for an association, particularly with chronic prenatal use, and simultaneously states that a causal relationship has not been established. That mixed message can feel unsatisfying in a headline. Yet it reflects honest science. Signals deserve caution, while clinical care must also treat fever and significant pain. Readers should expect more studies using biomarkers, genetics, and sibling comparisons. As those arrive, estimates may shift. Therefore, conclusions today are provisional by design, which is exactly how evidence-based medicine protects patients while knowledge grows.
The Dangers of Untreated Fever During Pregnancy
Patients sometimes ask whether they should avoid acetaminophen entirely. Clinicians answer with context. High maternal fever has been associated with adverse outcomes in pregnancy. Severe migraine and persistent pain can reduce sleep, worsen stress, and impair nutrition. Those effects can cascade in ways that also threaten the parent and fetus. Therefore, obstetric guidance balances symptom control against medication exposure and duration. Ibuprofen and other nonsteroidal anti-inflammatory drugs raise separate concerns in later pregnancy. This is one reason acetaminophen remains a first-line option when a clinician recommends treatment.
ACOG provides straightforward patient advice. It supports using acetaminophen in pregnancy when needed, in moderation, and after discussion with an obstetrician. The group recommends the lowest effective dose for the shortest necessary time. A clinician can also suggest non-drug strategies when appropriate, including hydration, rest, and cool compresses for fever. However, persistent high fever or significant pain should be treated. These points appear in ACOG’s patient-facing FAQ and professional materials. The language helps readers avoid two traps. One trap is any alarm that blocks needed care. The other is casual overuse that ignores dose and duration.
The FDA’s recent notice reinforces that balance. It advises clinicians to consider limiting prolonged use, yet it does not tell patients to stop all use. The agency highlights the difference between association and causation and encourages discussion with health professionals. That stance fits the total risk perspective that obstetrics has used for decades. Medicines are tools that can reduce risk when used wisely. Fever and pain are not harmless in pregnancy. Good care aims for relief with the smallest necessary exposure.
What the Courts Say
From 2022 to 2024, hundreds of federal lawsuits were combined in multidistrict litigation in the Southern District of New York. In August 2024, Judge Denise Cote entered final judgment for the defendants after excluding key expert testimony. In practical terms, the court found the plaintiffs’ proffered scientific evidence insufficient under the federal rules for expert reliability. Plaintiffs appealed. As of late 2025, the MDL docket shows the litigation history and filings, while separate state actions proceed on their own records. Court rulings do not settle science, yet they shape the legal environment around marketing and warnings.
The new Texas case is different because it invokes the state consumer-protection law. The Attorney General alleges deceptive marketing and seeks remedies that could affect label language and advertising. Kenvue has already filed submissions opposing similar labeling changes in a citizen-petition context and argues that credible scientific evidence does not support a causal link. The company also warns that overwarning can cause harm if patients avoid treating fever during pregnancy. Readers should expect the scientific debate to remain central in court, because legal claims still depend on reliable evidence. However, health guidance for families will continue to come from regulators and professional societies.
It helps to remember that law and medicine ask different questions. Courts ask whether expert opinions meet specific evidentiary standards and whether companies met legal duties. Clinicians ask what action best protects a patient today. Therefore, a dismissal can coexist with advisory updates, and a lawsuit can proceed while clinicians still recommend acetaminophen when it is indicated. However, that is not necessarily a contradiction. It is two systems doing different jobs, using different rules, in the same complex space.
Understanding the Studies on Tyenol and Autism
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Headlines often change from one outlook to another because study designs differ. When you see a new paper, first ask how exposure was measured. Self-reported pill counts can often miss doses. Biomarker studies may better reflect use, yet they can still be influenced by illness severity. Next, ask how the study dealt with confounding by indication. People use acetaminophen for fever, migraine, or chronic pain. Those conditions might influence neurodevelopment independently. If a study controls poorly for those conditions, estimates may drift.
Then consider the various family factors. Sibling designs and genetically informed methods help separate drug effects from shared traits. Recent large population studies using family comparisons show smaller or null associations after accounting for genetics and environment. That pattern suggests that part of the signal in earlier studies may reflect background factors. However, family designs have limits and can introduce new biases. Scientific progress often happens when multiple designs point in the same direction. Therefore, readers should look for convergence across methods, not a single dramatic number.
Finally, check the language being used. The FDA notice uses precise words. It says evidence suggests an association and adds that causation is not established. ACOG echoes that caution and still supports appropriate use. Yale’s Zeyan Liew summarizes it clearly: “We do not know yet for sure whether acetaminophen causes autism.” Those quotes are not hedges for their own sake. They reflect honest uncertainty that protects patients from both overreaction and complacency. If a headline sounds absolute, compare it with the exact text from agencies and journals. You will usually find a more measured core.
Practical Steps Patients Can Take
Many people want one rule, yet a small set of steps works better. First, talk with your obstetric clinician before taking over-the-counter medicines. Second, describe your symptoms, their onset, and anything that worsens them. Third, if acetaminophen is recommended, use the lowest effective dose and limit duration. Fourth, avoid stacking combination products that already include acetaminophen. Finally, check other medicines and supplements to prevent duplication. This process reflects ACOG’s patient guidance and remains consistent with the FDA’s current notice.
Non-drug strategies can help in selected cases. Hydration, rest, cool compresses for fever, and clinician-approved migraine strategies may reduce symptoms. However, persistent high fever or significant pain needs treatment. Untreated illness has consequences that can outweigh exposure from short-term, indicated use. Your clinician can also help if you face frequent migraines or chronic pain during pregnancy. A plan can reduce repeated exposure while protecting sleep, mood, and daily function. This is the kind of nuanced care that gets lost in loud debates, yet it is what protects families day to day.
A family physician resource for the public offers similar counsel. It explains that medical associations have not found proof of a causal link and that acetaminophen remains one of the safer options in pregnancy when used as advised. It also reminds readers that decisions should be individualized. Advice on the internet can be helpful, yet it cannot replace a conversation with a clinician who knows your history. That is especially true when symptoms persist or when pregnancy is complicated by other conditions.
Read More: RFK Jr. Claims Circumcised Boys At Higher Risk of Autism. Here’s What The Evidence Says.
How Politics and Messaging Affect Perception
Public statements from political leaders can overshadow measured advice from clinicians. In September 2025, national figures claimed a link between Tylenol and autism and urged broad avoidance. Medical groups pushed back within hours. ACOG said acetaminophen still has a place in pregnancy care when used as directed. The FDA issued its press announcement and physician notice the same day. Those documents acknowledged observational associations while reaffirming that causation is not established. Therefore, the official message to clinicians and patients remained careful and balanced.
Kenvue, which now markets Tylenol, also responded in regulatory filings. The company argued that the science does not support causal claims and warned that overwarning could keep patients from treating fever. Its petition response cites repeated FDA reviews over the past decade that did not find sufficient evidence to declare causation. Patients do not need to endorse any company’s view to see the public health point. Fear can change behavior in ways that create different risks, especially if people skip needed care or substitute less suitable medicines.
Texas’ lawsuit adds a legal theater to a scientific conversation. The press release asserts that companies ignored risks and deceived pregnant women. The complaint seeks changes to marketing and warnings under state law. Courts will sort those claims under legal standards, while clinicians will continue to follow evidence reviews. Families should keep their focus on care. That means staying in contact with clinicians, using medicines thoughtfully, and watching for updates from trusted organizations. That approach remains steady even when the news cycle turns noisy.
Where Consensus Currently Stands
Trusted institutions are converging on a middle-ground view. The FDA says evidence suggests an association in some studies, particularly with frequent or chronic prenatal use, yet causation is not established. ACOG states that acetaminophen remains the analgesic and antipyretic of choice in pregnancy. Yale researchers emphasize uncertainty and encourage better exposure measurement and triangulation across methods. A 2021 consensus statement urges minimizing dose and duration unless use is medically indicated, while a companion commentary notes that acetaminophen is still the safest available drug for fever and pain in pregnancy. Therefore, the careful path is responsible use guided by clinicians, not fear or denial.
These quotes may help make their view clearer. The FDA press announcement states, “a causal relationship has not been established.” ACOG writes that acetaminophen “remains the analgesic and antipyretic of choice during pregnancy.” Yale’s Zeyan Liew says, “We do not know yet for sure whether acetaminophen causes autism.” Those lines resist extremes and protect real patients. Headlines reward certainty. Medicine rewards good outcomes. The difference matters when your decisions affect a pregnancy. Patients can apply this consensus today by asking whether symptoms require treatment, using the smallest dose that works, and checking in with clinicians if symptoms persist. That process is not flashy, yet it is safe, respectful, and evidence-based.
The Bottom Line
When we read headlines like “Texas sues Tylenol makers”, what should we make of it? After all, families deserve clarity, not confusion. In 2025, the FDA moved to update labels and notified physicians about studies that suggest an association between frequent prenatal acetaminophen use and some neurodevelopmental outcomes. The agency said causation is not established. ACOG reaffirmed that acetaminophen still has a role in pregnancy care when used as directed. Texas filed a lawsuit that will play out under state law, while the federal MDL remains closed pending appeal. None of those developments changes a simple clinical truth.
Untreated fever and significant pain can be risky in pregnancy, yet careless medicine use is also unwise. Therefore, the safest path is shared decision-making. Talk with your clinician before taking over-the-counter medicines. Use the lowest effective dose for the shortest necessary time when treatment is indicated. Avoid chronic or routine use without medical advice. Watch for updates from the FDA, ACOG, and reputable academic groups. That approach protects parents and babies today, while science continues to refine tomorrow’s guidance.
Disclaimer: This article was created with AI assistance and edited by a human for accuracy and clarity.
Read More: How The WHO’s Autism ‘Causes’ Stack Up Against RFK Jr’s Tylenol Claim