Following US President Donald Trump’s claims that Tylenol (acetaminophen) use in pregnancy can cause autism, the US Food and Drug Administration (FDA) has hit the drug with a label change.
From now on, makers of the common over-the-counter (OTC) medication – otherwise known as paracetamol – are required to warn pregnant users of the drug’s capacity to “increase the risk of neurological conditions such as autism and ADHD in children”.
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Following Tylenol’s label change, FDA commissioner Marty Makary distributed a note to physicians across America, which set out to discourage the use of acetaminophen in pregnant women.
However, within this letter, Makary disclosed that acetaminophen is still “the safest OTC alternative in pregnancy among all analgesics and antipyretics” currently on the market. In addition, he acknowledged that “while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature”.
Across the pond, British and European health authorities were hasty to speak out against Trump’s Tylenol allegations, with the European Medicines Agency’s CMO Steffen Thirstrup and UK Health Secretary Wes Streeting both stating that there is no evidence to link paracetamol use in pregnancy to autism.
This sentiment was echoed by the Autism Science Foundation (ASF), with the organisation’s CSO, Alycia Halladay, stating that Trump’s statements around Tylenol and its link to autism were “dangerous”.
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By GlobalDataShe said: “Any association between acetaminophen and autism is based on limited, conflicting, and inconsistent science and is premature.
“This claim risks undermining public health while also misleading families who deserve clear, factual information.”
Trump clamps down on autism
In another move under the Trump administration’s wider ploy to curb the “autism epidemic” allegedly facing the US, the FDA greenlit GSK’s Wellcovorin (leucovorin) – a type of folate – for use in patients with cerebral folate deficiency (CFD), a rare condition characterised by autistic features.
This makes Wellcovorin the first ever drug to gain regulatory endorsement for the treatment of autism.
However, the ASF has strong reservations about Wellcovorin’s approval in this indication, as the non-profit believes that the current science upon which the drug’s approval was based is insufficient to prove its efficacy and safety.
In a 22 September statement, the organisation noted that the science behind leucovorin in autism is “still in very early stages”, and that more studies will be necessary before a definite conclusion can be reached. Based on this, the ASF does not currently recommend Wellcovorin as a treatment for autism.
Despite being an advocate for natural products, including folate supplementation, nutraceutical consultant Blake Ebersole was also alarmed by Wellcovorin’s approval.
He stated: “Only a small portion of autism cases – those with cerebral folate deficiency due to the over-expression of folate receptor-alpha autoantibodies – are likely to benefit.
“Plus, studies cited in support of the approval have modest outcomes, have small populations and show no benefit for subjects without these autoantibodies.”
