Last month, I reported the FDA would be issuing notifications to doctors regarding the use of the pain reliever acetaminophen during pregnancy out of concern for possible connections to autism and adverse impacts on neurodevelopment.
Subsequently, there were social media posts of pregnant women taking Tylenol in protest of this move by the Trump administration, especially the head of Health and Human Services, Sec. Robert F. Kennedy, Jr.
This week, Texas Attorney General Ken Paxton filed a lawsuit against Johnson & Johnson and Kenvue, the current and former makers of Tylenol (i.e., acetaminophen). The suit alleges deceptive marketing and failure to warn consumers, namely pregnant women, about the alleged risks of autism and other neurodevelopmental disorders associated with the drug.
The makers of Tylenol, Johnson & Johnson (JNJ.N), and Kenvue (KVUE.N), were sued on Tuesday by Texas Attorney General Ken Paxton, who accused them of knowingly hiding the drug’s supposed links to autism and attention deficit hyperactivity disorder.Paxton, a Republican, sued five weeks after Republican President Donald Trump said using Tylenol during pregnancy can cause autism in children. Trump is not a doctor, and his claim is unproven and not backed by scientific evidence.The Reuters Daily Briefing newsletter provides all the news you need to start your day. Sign upJohnson & Johnson sold Tylenol for more than six decades, and its former Kenvue unit has sold it since 2023 after being spun off.The pain reliever is known generically as acetaminophen. Doctors and medical societies consider acetaminophen the best option for treating fever and pain during pregnancy.
The current manufacturer of Tylenol refutes these claims.
In a statement, Kenvue pushed back on the attorney general’s claims, saying it is “deeply concerned by the perpetuation of misinformation on the safety of acetaminophen and the potential impact that could have on the health of American women and children.””Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives. High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated,” the statement read.
Texas is working with a law firm experienced in dealing with cases involving corporate behemoths.
Dozens of people have filed personal injury lawsuits against Johnson and Johnson, and its corporate spin-off, Kenvue, alleging adverse neurodevelopment outcomes for their children after taking Tylenol while pregnant.Those cases have been consolidated into multi-district litigation, which is still making its way through the courts and being led by Ashley Keller of Chicago law firm Keller Postman. Keller has represented Texas in litigation against Google and Meta, and has been contracted by the attorney general’s office to handle this new lawsuit against Johnson and Johnson.“[Paxton] figured I knew the science, I knew the history, I knew a lot of the moving parts,” Keller said in an interview. “And so I’d be an obvious choice to pursue this for Texans.”Paxton, who is running in the GOP primary to unseat U.S. Sen. John Cornyn, said in a statement announcing the lawsuit that “by holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”
Meanwhile, Kennedy recently encouraged caution when using acetaminophen during pregnancy, while underscoring there is not “sufficient” evidence to link Tylenol to autism, but rather “suggestive”.
“The causative association… between Tylenol given in pregnancy and the perinatal periods is not sufficient to say it definitely causes autism. But it is very suggestive,” Kennedy told reporters, citing animal, blood and observational studies.”There should be a cautious approach to it,” he added….Asked if Kennedy’s latest comments signaled a softening of his stance on the issue, Emily G. Hilliard, Health and Human Services press secretary, said: “It’s the same position the Secretary has had since the beginning.”
I will simply point out that in science, “suggestive evidence” means there are some observations or studies supporting a possible association or hypothesis, but the evidence is limited, inconsistent, or cannot confidently rule out other factors like chance, bias, or confounding.
“Sufficient evidence” is a higher standard, indicating there is enough robust, high‐quality, and consistent data across multiple studies to reliably establish an association, minimizing alternative explanations.
Given the current data set, I would say the cautious approach of informing women and their doctors and allowing them to reach their own conclusions and decide the appropriate course of action would be best.
But, then again, I am not suffering from TDS nor trying to get views on my TikTok account.
Meanwhile, discovery in this case should be…fascinating.
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