As Pregnant Women Make Videos Taking Acetaminophen in Protest, Tylenol’s Own Guidance Says That Might Not Be Recommended

The U.S. Food and Drug Administration (FDA) has announced a significant action to update the labeling for acetaminophen products, including Tylenol, to reflect emerging evidence of a possible association between its use during pregnancy and an increased risk of neurological conditions in children, such as autism and ADHD. This development, detailed in a recent FDA news release, has prompted a broader discussion about the medication’s safety for expectant mothers.

According to the FDA, the decision stems from a review of scientific evidence suggesting a correlation between acetaminophen use by pregnant women and subsequent diagnoses of conditions like autism and ADHD. Multiple large-scale cohort studies have contributed to this body of evidence, with some research indicating that the risk may be more significant when acetaminophen is taken regularly throughout pregnancy. In response, the agency has initiated a label change for these products and issued a letter to physicians nationwide to ensure they are informed about these potential risks.

“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”

The FDA emphasizes that while an association has been described in numerous studies, a causal relationship has not been definitively established, and contrary studies also exist in the scientific literature. It is also important to recognize that acetaminophen is the only over-the-counter medication currently approved for treating fevers during pregnancy, and high fevers in expectant mothers can pose risks to their children. Furthermore, the FDA states other common pain relievers like aspirin and ibuprofen have well-documented adverse effects on fetal development.

As a response to this announcement and potential misunderstanding of what was actually being recommended by the FDA, multiple pregnant women are now posting videos of themselves on social media taking Tylenol while pregnant. However, Tylenol’s own guidance says this might not be a good idea.

A 2017 social media post from the Tylenol X (formerly Twitter) account has resurfaced and gone viral on social media. In that post, Tylenol stated, “We actually don’t recommend using any of our products while pregnant. Thank you for taking the time to voice your concerns today.” The post was a reply to another post on X, which has been deleted.

We actually don't recommend using any of our products while pregnant. Thank you for taking the time to voice your concerns today.

— TYLENOL® (@tylenol) March 7, 2017

The company’s current guidance, as presented on its website, emphasizes that credible, independent scientific data continues to show no proven link between taking acetaminophen and autism. Tylenol highlights that major medical and public health organizations, including the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the Autism Science Foundation, and the American Academy of Pediatrics, agree with this assessment.

Tylenol’s current advice directs pregnant individuals to consult their healthcare professional before taking or administering acetaminophen, as stated on their product labels. The company asserts that healthcare providers are best equipped to advise on the appropriateness of the medication based on individual medical conditions. For parents treating children with acetaminophen, Tylenol reiterates that there is no credible science demonstrating that the medication causes autism. They advise consulting a healthcare provider for guidance on suitable pain and fever relief for infants and children, stressing the importance of adhering to dosage instructions on product labels or as directed by a medical professional. For Infants’ TYLENOL®, specific dosing information for children under 2 years of age requires consultation with a doctor.

Impact on Pregnant Individuals and Families:

Pregnant individuals and those planning to become pregnant should be aware of the FDA’s updated guidance and the ongoing scientific discussion surrounding acetaminophen use. While the FDA is initiating label changes to reflect potential risks, it also acknowledges that acetaminophen remains an option for fever management in pregnancy when other alternatives are contraindicated or ineffective. The most crucial takeaway for families is to maintain open communication with their healthcare providers. Discussing any concerns about medication use during pregnancy or for young children is paramount. Healthcare professionals can provide personalized advice based on individual health histories and the latest scientific understanding, helping to make informed decisions about managing pain and fever.

Article by Ken Buckler, based upon information from the U.S. Food and Drug Administration and Tylenol’s FAQ.

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