U.S. President Warns Pregnant Women Against Tylenol Use Amid Autism Concerns

In a recent development, the U.S. President has issued a warning to pregnant women, advising them to avoid using Tylenol, a popular over-the-counter pain reliever. The warning comes amid claims that the drug's active ingredient, acetaminophen, may be linked to autism. This announcement has sparked a debate within the scientific community and raised concerns about the safety of acetaminophen during pregnancy.

The President, during a joint activity with the U.S. Secretary of Health, stated that the use of Tylenol is not advisable and strongly recommended that women limit its use during pregnancy unless medically necessary. This statement was made despite the lack of widely accepted scientific evidence supporting the claim that acetaminophen is linked to autism. The U.S. government has also announced plans to modify the safety labels of related medications and launch a nationwide public health awareness campaign.

The manufacturer of Tylenol, Kenvue, has released a statement asserting that independent and reliable scientific research indicates that the use of acetaminophen does not cause autism. However, the scientific community remains divided on the issue. Some scientists have warned against prematurely discontinuing the use of acetaminophen by pregnant women, as it is the only recommended fever reducer during certain stages of pregnancy. They argue that untreated fever for extended periods can harm fetal development.

Acetaminophen, classified as an "antipyretic analgesic" in pharmacology, is commonly recommended for pregnant women as an alternative to ibuprofen for fever reduction. Over the past decade, numerous studies have explored the potential link between acetaminophen and autism, but the results have been inconclusive. A 2021 review published in the journal Nature Reviews Endocrinology called for cautious use, while a large-scale study published in 2024, analyzing data from nearly 2.5 million siblings in Sweden, found no increased risk of autism in offspring whose mothers used acetaminophen during pregnancy.

Professional organizations, including the American College of Obstetricians and Gynecologists, have also expressed concerns, stating that patients should not be deterred from the benefits of acetaminophen due to fear. The U.S. Food and Drug Administration (FDA) has stated that it has not found clear evidence that the appropriate use of acetaminophen during pregnancy leads to adverse pregnancy outcomes, birth defects, or developmental issues.

Prior to the President's warning, the controversy surrounding acetaminophen had already entered the legal arena. Numerous lawsuits in the U.S. have alleged that exposure to Tylenol during pregnancy caused autism in children. However, in 2023, a U.S. district judge dismissed these lawsuits, citing "flawed science" and excluding the testimony of the plaintiff's expert witness, Andrea Baccarelli, for lacking sufficient rigor in assessing the link between acetaminophen and neurodevelopmental disorders. The plaintiffs have since appealed, and the case is expected to be argued in Manhattan later this year. Legal experts suggest that the HHS statement on autism may be considered by the appellate court but will not replace the legal standards for admissible evidence.

In response to the ongoing debate, the U.S. Secretary of Health has indicated that the FDA will issue a physician notification regarding the risks of acetaminophen use during pregnancy and initiate a process to change the drug's safety labeling. This move signals increasing regulatory pressure, despite ongoing legal disputes. The scientific community continues to grapple with the complexities of acetaminophen's potential risks and benefits, emphasizing the need for further research and cautious use during pregnancy.