For almost ten years, the Food and Drug Administration (FDA) has overlooked its own experts’ recommendations regarding Tylenol safety for pregnant women, according to an internal report and presentation disclosed recently.
The FDA’s general scientists have consistently urged that the potential risks of Tylenol during pregnancy be clearly communicated. They presented their findings in scientific reviews from 2016, 2019, and 2022, in addition to memos from 2016 and 2017 regarding maternal and urinary health.
While genetics is the most established contributor to autism, FDA officials acknowledged that the research linking Tylenol to autism is still rather uncertain. Yet, despite the growing alarm at FDA and among Tylenol manufacturers, there was no public warning for pregnant women until a recent announcement from President Donald Trump and Secretary of Health and Human Services Robert F. Kennedy Jr. in September.
The FDA has so far refrained from updating its webpage on over-the-counter painkillers during pregnancy, reiterating a statement from January 2015, which only acknowledged concerns about Tylenol and attention-deficit/hyperactivity disorder (ADHD) without citing specific studies.
In response to Trump and Kennedy’s call, the FDA finally warned about Tylenol in September, around nine years after it was first suggested by drug safety experts. The warning acknowledged that other pain relievers like aspirin and ibuprofen also come with their own risks.
Documents obtained by the Daily Caller News Foundation (DCNF) were from Keller Postman LLC, a law firm involved in a class action lawsuit against Tylenol’s manufacturer, Kenvue, which is a new spin-off of Johnson & Johnson. The legal team accessed these documents through the Freedom of Information Act.
Tylenol, or acetaminophen, has been available since 1955, prior to the introduction of tougher drug laws and clinical trial requirements in the early 1960s.
Some experts suggest that the neurological damage might be due to a toxic byproduct of acetaminophen known as NAPQI. It’s believed that babies and children with autism may find it harder to process drugs, leading to elevated levels of NAPQI, which can be harmful to cells.
Most autism specialists recognize that various genetic and environmental factors contribute to autism risk. Kennedy has pointed out that certain traits associated with autism may hinder the metabolism of acetaminophen.
“When you consider all evidence, especially the factors influencing autism risk, it indicates how acetaminophen may be more or less risky for each person,” commented William Parker, CEO of WPLab, who has discussed the issue with Kennedy.
2014 Warning Signs
Internal FDA memos indicate that the agency started examining acetaminophen’s effects during pregnancy back in May 2014, following a much earlier study from April 2004. A 2014 study published in the Journal of the American Medical Association raised concerns surrounding drugs and ADHD-like behaviors, but the FDA did not make a significant statement on the topic for nearly a decade.
In January 2018, an FDA committee led by Janet Woodcock reviewed various studies, finding that a significant number indicated risks associated with Tylenol use during pregnancy. However, the FDA ultimately decided against changing any drug labels and postponed additional statements for a further six months, citing a need for more studies.
At a follow-up meeting later in 2018, FDA scientists suggested that Tylenol might affect blood flow to developing infants, though many details from the discussions are redacted in the documents retrieved by DCNF.
A 2019 epidemiological study also identified a link between Tylenol use during pregnancy and reproductive tract issues in newborns. “These findings indicate that the use of acetaminophen during pregnancy is not without risks,” Mosholder noted in his remarks on the matter.
The latest reviews keep reiterating mixed findings, with one stating that existing studies may not provide the clarity needed for a definitive recommendation regarding Tylenol use during pregnancy.
Ongoing Legal Challenges
A significant upcoming review concerning Tylenol’s safety will take place in November at the Second Circuit Court of Appeals, involving a class action lawsuit filed by Keller Postman against Kenvue. Legal representatives noted a notable increase in calls to the company following the recent announcement.
A ruling from a lower court previously dismissed claims of a causal relationship between Tylenol and autism, with some experts warning that ongoing lawsuits might limit access to Tylenol for pregnant women.
While FDA officials acknowledged a consistent association between Tylenol and autism, they emphasized that the evidence doesn’t meet causation standards due to limitations in study methodologies and autism diagnosis techniques.
In five out of six internal FDA evaluations, it was deemed essential for pregnant women to receive information about potential risks concerning Tylenol. However, the Biden administration’s Justice Department focused solely on the most recent review, which failed to provide advisory recommendations for the public.
