No link between paracetamol in pregnancy and autism, UK charities say

Autism charities in the UK have issued a joint statement about new claims from the US Department of Health and Human Services (HHS) about a link between autism and the use of Tylenol (paracetamol) by pregnant women.

Ambitious about Autism, Autism Alliance, Autistica and National Autistic Society said that the evidence to suggest paracetamol use in pregnancy increases the likelihood of a baby being autistic is very weak and based on poorly conducted studies.

They added that high-quality, well-controlled studies suggest there is no link between paracetamol in pregnancy and autism. Pregnant people should, therefore, continue to follow existing NHS advice.

The claims were part of an announcement from President Donald Trump and the US Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., promising “bold new actions to confront the nation’s autism spectrum disorder (ASD) epidemic”, that now affects one in 31 American children.

The US Food and Drug Administration (FDA) said it was responding to prior clinical and laboratory studies that suggest a potential association between paracetamol (US name acetaminophen) use during pregnancy and adverse neurodevelopmental outcomes. It also recognises that contrary studies are showing no association and that there can be risks for untreated fever in pregnancy, both for the mother and fetus.

The HHS now encourages clinicians to exercise their best judgment in using paracetamol for fevers and pain in pregnancy by prescribing the lowest effective dose for the shortest duration when treatment is required.

Leucovorin as treatment for “autistic symptoms”

The FDA will also act on a potential treatment for speech-related deficits associated with autism. It is publishing a Federal Register notice outlining a label update for leucovorin for cerebral folate deficiency, which will authorise treatment for children with autism.

Leucovorin, also known as folinic acid, is a form of folate, which is an essential B vitamin. In the UK, it is primarily used to mitigate the harmful effects of chemotherapy.

The FDA cited a review of the use of leucovorin in 40 patients with a rare metabolic disorder called cerebral folate deficiency that can lead to a range of neurological symptoms, some of which are seen in people with autism.

Researchers at SUNY Downstate Medical Center in Brooklyn, New York, say that up to three-fourths of children with autism have genetic variations that impair their body’s ability to process folate or autoimmune disorders that block folate transport to the brain. Other small studies have linked these findings with more severe forms of the disorder and suggested that treatment with leucovorin can improve verbal skills, social skills and irritability in these youngsters.

In the US, continued use of leucovorin will be approved if children show language, social, or adaptive gains. The National Institutes of Health (NIH) will launch confirmatory trials and new research into the impact of leucovorin, including safety studies.

The US HHS, however, added that while promising, it is important to note that leucovorin is not a cure for autism and may only lead to improvements in speech-related deficits for a subset of children. Furthermore, this treatment must be administered under close medical supervision and in conjunction with other non-pharmacological approaches for children with ASD (e.g., behavioral therapy).

No cure for autism

The UK coalition of autism charities agreed that there are no proven therapies or drugs that ‘cure’ autism and said that most autistic people and families want research to focus on better understanding and support.

They added: “The Trump administration has regularly referred to rising rates of autism and named various incorrect causes. The rising rates of autism that we have seen in recent years are most likely due to increased awareness and changes to diagnosis. Hundreds of studies have been carried out to look at the causes of autism, but none have found a major environmental cause.

“We are concerned by the multiple recent inaccurate claims from the Trump administration. These claims are not only stigmatising, but they are a distraction and act as an impediment to progress. As a group of charities that exist to make the world better for autistic people, we want to see governments focusing on following high-quality evidence to help autistic people thrive instead of focusing on disproven theories.”

Dr Susan J. Kressly, President of the American Academy of Pediatrics also said that the White House event on autism was filled with “dangerous claims and misleading information that sends a confusing message to parents and expecting parents and does a disservice to autistic individuals.”

She added: “Regarding autism, we know it is complex, highly variable and increasingly linked to genetics. There is no single, root cause of autism, and there is no single medication that will give every autistic child or adult what they need.”

The NIH also announced $50 million in funding for autism research to examine environmental, nutritional, medical, and social factors in conjunction with genetics.

Alison Bloomer

Alison Bloomer is Editor of Learning Disability Today.

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