In a bold assertion that could raise eyebrows across the border, Health Canada has declared that there is insufficient evidence to suggest that using Tylenol during pregnancy could result in autism or other neurological disorders. This declaration arrives on the heels of a recent statement from the U.S. Federal Drug Administration (FDA), which posited a potential correlation between acetaminophen—Tylenol’s active ingredient—and autism spectrum disorders.
Following the FDA’s proclamation on September 22, which hinted at an escalated risk of neurological conditions associated with acetaminophen use in pregnant women, Health Canada weighed in with its own assessment. The agency confidently asserted, “Health Canada currently maintains that there is no conclusive evidence that using acetaminophen as directed during pregnancy causes autism or other neurodevelopmental disorders,” according to a statement released on September 23.
This stance is purportedly grounded in “robust, rigorous assessments of the available scientific evidence,” with Health Canada promising to scrutinize any new data that might come to light.
In stark contrast, the FDA’s recent actions include mandating updates to acetaminophen labeling to reflect possible autism risks, paving the way for what could become a fraught debate between scientific interpretations. This move is partly fueled by a comprehensive literature review, encompassing 46 earlier studies, which suggested a troubling association between prenatal exposure to acetaminophen and later onset of autism.
Notably, one of the researchers behind this significant review, Diddier Prada from the Icahn School of Medicine at Mount Sinai, remarked that higher-quality studies exhibit a greater likelihood of establishing a link between prenatal exposure to acetaminophen and elevated autism and ADHD risks.
Despite the brewing controversy, Health Canada continues to endorse acetaminophen as a viable option for pain and fever management during pregnancy, emphasizing that the medication has been employed safely by millions of Canadians for years, including during pregnancy and lactation. Their advisory suggested using the “lowest effective dose” for the “shortest duration” necessary, reinforcing that untreated fever and pain in a pregnant woman could pose risks to the developing fetus.
Pregnant women with concerns are counseled to consult healthcare providers for tailored advice, ensuring that any decisions reflect individual health circumstances.
In a clear rebuttal to the FDA’s concerns, a spokesperson from Kenvue, the parent company of Tylenol, expressed disagreement with the regulatory body’s findings. They stressed that “independent, sound science” indicates no causal link between acetaminophen and autism. Their statement underscores a worry about the health implications of the FDA’s stance for expectant mothers.
Zachary Stieber contributed to this report.
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