Paracetamol use in pregnancy | Therapeutic Goods Administration

Warnings from Donald Trump that acetaminophen (popular brand name Tylenol), also known as paracetamol (popular brand name Panadol) has a causative link to autism when taken by pregnant women are unsupported and rejected by health authorities world wide.

Absurdly, his ramblings were a unilateral seizure of what was apparently a planned nuanced announcement, prepared by his own so-called health administration. They intended a caution on Tylenol, a supposed treatment for autism and to reveal $50 million for autism research.

Using his feelings and purported anecdotes, Trump urged pregnant women to “fight like hell” against paracetamol. He reasoned with a bizarre risk-benefit myth that not taking the drug meant only good things would happen, opposed to the risk of bad things, if women took the drug. Yet the reality is that paracetamol/acetaminophen is necessary to combat fevers women may experience during pregnancy and that failure to treat fever can cause neurodevelopmental disorders for the unborn child. These include autism, ADHD or developmental delay. Another identified risk is miscarriage.

Trump also used vague anecdotes to link the vaccine schedule to childhood death and harm. There is no evidence for either Trump’s tale of vaccines killing the child of an employee, and no scientific evidence to justify the changing of vaccination schedules. Trump argued the Hepatitis B vaccine should be held off until 12 years. Yet the primary source of exposure for infants and children is maternal, not sexual activity as claimed by Trump. He further suggested spacing out Measles, Mumps and Rubella vaccines as well as other combined vaccines. The apparent logic is that children are given too many antigens at once.

In fact, children receive fewer antigens today to combat a greater range of disease. Thirty years ago 30,000 antigens were required to encourage immunity against 8 diseases. Today’s US vaccine schedule uses 305 antigens to tackle 14 diseases. And active children take on 2,000 – 6,000 antigens daily through eating, playing and even breathing.

Pregnant women should fight like hell to ignore Donald Trump’s monumental woo.

Therapeutic Goods Administration Statement – 23 September 2025

  • Australia’s Chief Medical Officer and the TGA join with other global medicines regulators, leading clinicians and scientists worldwide in rejecting claims regarding the use of paracetamol in pregnancy, and the subsequent risk of development of ADHD or autism in children.
  • Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims.
  • Paracetamol remains the recommended treatment option for pain or fever in pregnant women when used as directed. Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with recommended treatment. Pregnant women should speak to their healthcare professionals if they have questions about any medication during pregnancy.
  • Paracetamol remains pregnancy category A in Australia, meaning that it is considered safe for use in pregnancy when used according to directions in TGA-approved Product Information (PI) and Consumer Medicines Information (CMI) documents.
  • This means that a medicine has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other harmful effects on the fetus having been observed. As with the use of any medicine during pregnancy, people who are pregnant should seek medical advice tailored to their specific circumstances before taking paracetamol.
  • The TGA is responsible for ensuring the safety, quality and efficacy of medicines on the Australian Register of Therapeutic Goods (ARTG), with safety in pregnancy a key consideration for all products on the ARTG.
    The TGA undertakes evaluation of clinical, scientific and toxicological data prior to registration of a medicine, and this information is summarised in TGA-approved PI and CMI documents, targeted at healthcare professionals and consumers respectively, to help support safe use of a medicine in the community. These documents include information relating to use of a medicine in pregnancy.
  • The TGA is aware of announcements by the US Administration that use of paracetamol in pregnancy may be associated with an increased risk of autism and ADHD in children, though a causal association has not been established.
  • TGA advice on medicines in pregnancy is based on rigorous assessment of the best available scientific evidence. Any new evidence that could affect our recommendations would be carefully evaluated by our independent scientific experts.
  • Whilst there are published articles suggesting an association between maternal paracetamol use and childhood autism, they had methodological limitations. More recent and robust studies have refuted these claims, supporting the weight of other scientific evidence that does not support a causal link between paracetamol and autism or ADHD.
  • The TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol. This includes detailed analysis of adverse event reports made by medicine consumers, clinicians and pharmaceutical companies, review of published medical literature, and close liaison with international medicines regulators. If a safety issue is confirmed prompt regulatory action is taken to mitigate risks.
  • International peer regulators including the Medicine and Healthcare products Regulatory Agency (MHRA) in the United Kingdom have reiterated that paracetamol should continue to be used in line with product information documents. Following evaluation in 2019 the European Medicines Agency (EMA) found that scientific evidence regarding effects of paracetamol on childhood neurodevelopment was inconclusive.
  • People who have concerns and are pregnant, or considering pregnancy, are advised to consult their healthcare professionals in the first instance to discuss this issue. [Source ©️ TGA]

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“I didn’t know that”: RFK Jr. offers genuine insight

As US Secretary of Health and Human Services, Robert F. Kennedy Jr. has overseen financial and staffing cuts to infectious disease, mental health and addiction services. However, he appears to be unaware of this and the extent of the harm he has caused.

In trying to ascertain exactly where his head is at, consider his visit to the unvaccinated Mennonite community in Seminole, Texas, where a measles epidemic rages, killing children and nearly killing others. Kennedy posted on X about his visit with a couple whose 2 year old daughter was discharged after 3 weeks in Intensive Care. He also offered:

I also visited with these two extraordinary healers, Dr. Richard Bartlett and Dr. Ben Edwards who have treated and healed some 300 measles-stricken Mennonite children using aerosolised budesonide and clarithromycin.

Healed? Really?

Well, no. Nothing “heals” measles. There is no cure. Richard Bartlett has previously claimed budesonide was a miracle cure for COVID-19. His extensive research involved being asleep during which time “an answer to a prayer” came to him. With patent laws on divine intervention being sketchy at best, it’s no surprise that this is now a cure for measles. So, what is aerosolized budesonide when it’s at home? A bronchodilator, often simply called an asthma inhaler, after its most common use. As noted in the video below, Dr. Paul Offit warns of the immune inhibiting qualities of steroids like budesonide and the obvious danger this poses during measles infection.

The other “extraordinary healer”, Ben Edwards, has recently volunteered that mass infection is “God’s version of measles immunisation”. This guy is peddling prayer and unproven treatments whilst wandering about his so-called clinic, himself infected with measles. When devotees from the Kennedy-founded anti-vaccine lobbyist group, Children’s Health Defense praise him for his negligence he offers, “I’m only doing what any good doctor should be doing”.

So here we are, now getting an idea of how US public health initiatives unfold under Kennedy. I wonder if this is what Trump had in mind when he said “Go wild Bobby”. To make the whole thing even more bizarre is the fact other anti-vaccine identities are criticising Kennedy for observing, tucked at the bottom of another post on X, that the MMR vaccine is “the most effective way to prevent the spread of measles”. They may be happier with the falsehoods he has since announced about “treating” measles (you can’t) that cases are inevitable because the vaccine “wanes very quickly” (it doesn’t), and 14 studies not linking autism to vaccines are “invalid” (no evidence provided) .

With her apt tone, Rachel Maddow runs through a few of Kennedy’s recent failures, in the MSNBC video below…

Vaxxed III: Unmitigated disinformation

On 23 August this year, Robert F. Kennedy Jr. suspended his independent US presidential campaign in ten battleground states, choosing to endorse Donald Trump. He cited the same causes, “that persuaded me to leave the Democratic Party and run as an independent”, according to AP News. Namely, free speech the war in Ukraine and “a war on our children”.

Kennedy: Anti-vaccine activist

There is, of course, no war on American children. Nor a war on any children in developed nations, in the sense Kennedy is alluding to. In fact as the chairman of Children’s Health Defense (CHD), Kennedy has himself waged a long battle against one of public health’s most important pillars; childhood immunisation. As with every anti-vaccine activist, COVID-19 presented Kennedy with an opportunity to manipulate and exploit a growing pool of misguided and misinformed individuals. Those who blame COVID-19 vaccines for virtually every illness or cause of death. Let me stress, I’m not referring to the known side effects but rather, those pushed by COVID conspiracy theorists and tireless anti-vaxxers. Ultimately, Kennedy’s profile expanded markedly, as did CHD revenue.

So comfortable with deceit, when he began his independent trot toward the White House, Kennedy insisted he was not anti-vaccine. This, despite telling a supportive crowd in December 2021, “It is criminal medical malpractice to give a child one of these vaccines”. Despite his influence in bringing about the measles tragedy in Samoa. He worked hard at the presidential pretence, even temporarily stepping down from his position as CHD Chair. Still today, the “chairman on leave” video message on every CHD website page lacks any reference to vaccines. Yet Kennedy mentions “unnecessary injuries” suffered by children, includes studies of autism and developmental disorder rates and packs in 16 snippets of autistic individuals – mostly with pronounced symptoms. Children are chronically sicker than ever before, “wandering around in a toxic soup”, Kennedy tells viewers. In search of the cause he will die with his boots on, fighting for them. Kennedy originally wrongly linked vaccines to autism in a, now removed, 2005 Rolling Stones article. This fact check piece offers an excellent deconstruction of the misconceptions used to make that link.

Vaxxed

Kennedy’s Children’s Health Defense has been hard at work targeting vaccine evidence during the COVID pandemic. This includes the making of the third Vaxxed film, Vaxxed III: Authorised to Kill, by CHD Films. True to the Vaxxed brand, it is a slick cornucopia of fear-mongering and falsehood. A key figure in this ghastly enterprise is interviewer and co-producer Polly Tommey, who has been involved with the first two Vaxxed films. Readers may remember Tommey was banned from Australia for three years following her antics in promoting the original Vaxxed film here in 2017. Trundling about with the (then) Australian Vaccination-skeptics Network, Tommey, who wrongly believes the MMR vaccine caused her son, Billy, to develop autism, told Australian audiences “doctors were murderers”. The Tommey named as producer of Vaxxed III and Vaxxed II: The people’s truth, is her other son, Tobias. The second and third Vaxxed films have been directed by Brian Burrowes. The first Vaxxed was directed by Andrew Wakefield and produced by Del Bigtree.

In doing some basic research for this post, I noted that Polly Tommey has changed not at all. On 6 September she used CHD’s X account to peddle the falsehood that “an experimental” oral polio vaccine is being used in Gaza. She added the sweeping claim that “the oral polio vaccine” is responsible for the poliovirus infecting “hundreds each year”. Like most persistent anti-vaccine lies there is a kernel of truth here. A prior oral polio vaccine caused disease in ~1 in 2.9 million. However, the new oral vaccine in Gaza does not contain the vaccine-derived strain responsible for past infections. More so, it is the lack of vaccination and the presence of poliovirus in human waste causing the problem. In addition, removal of the problematic weakened virus in 2016, in an attempt to prevent vaccine-derived outbreaks, resulted in greater infection rates. Citing a draft report for the World Health Organisation, AP News explain:

The polio strain in question evolved from a weakened virus that was originally part of an oral vaccine credited with preventing millions of children worldwide from being paralyzed. But that virus was removed from the vaccine in 2016 in hopes of preventing vaccine-derived outbreaks.

Public health authorities knew that decision would leave people unprotected against that particular strain, but they thought they had a plan to ward off and quickly contain any outbreaks. Instead, the move resulted in a surge of thousands of cases.

Suffice it to say, facts are anathema to CHD and Tommey. Which brings us to the quality of Vaxxed III: Authorised to Kill. As with the prior two films the main content is of people interviewed about so-called “vaccine injuries”, deaths and negative health system experiences, filmed in a Vaxxed bus driving across the USA. Like all Vaxxed buses this one was wrapped in Vaxxed brand colour and font. This time the message was Vax – UnVax: The People’s Study. The journey took nine months. All the COVID-19 anti-vaccine tropes are there. Countless testimonies of “life-altering injuries and deaths”, frightening symptoms, scans of brain tumours and pulmonary bleeds, suicidal tendencies and futile hospitalisations. Whistleblowers, medical professionals and lawyers apparently serve to legitimise what is unmitigated disinformation. Viewers are primed to accept that any response to COVID was a “fundamental violation of human rights”.

Vaxxed films are slick productions. Well edited to give the impression of government and health-authority deception, feeding viewers a misleading narrative that casts vaccines as harmful toxins pushed onto an unsuspecting public for nefarious reasons. A conspiracy to hide the truth is always present. As with all Vaxxed buses the names of the “vaccine injured” and dead are written on the outside of the bus. The dedication page for these most recent names contains over 1,350 entries, many of which list autism from MMR or “childhood vaccinations”. Apart from harm done to perception of vaccine safety and public health, individuals exploited and coaxed into a victim mindset, experience genuine pain and distress. Nothing good comes from these films.

Message on the CHD Vaxxed bus

This latest Vaxxed chapter raises a few questions for those of us in Australia who followed the antics of The Australian Vaccination-risks Network (AVN) and their much troubled journeys in their own Vaxxed II: The People’s Truth, bus. The AVN hit the road in July 2020 in their bus, sticking closely to the Vaxxed script. They clocked up seven seperate tours in two buses, as the first was irreversibly damaged in NSW flood waters. On 8 July 2020, AVN founder Meryl Dorey revealed parents “will be filmed for an up-coming Australian documentary”. Five weeks earlier president Anita Hafemeister had boldly claimed, “This will be the Australian version of Vaxxed II, I assume”. All that excitement led this humble author to speculate that the Vaxxed II bus tour would yield material for Vaxxed III. In fact the AVN was still advertising the bus, with sponsorship requests, in February this year. One can only assume that the reality of CHD dollars, Kennedy’s backing and the ambition of Polly Tommey has for now, kept content from Down Under off the big screen.

Polly Tommey and CHD are pushing to fill theatres in the US for an 18 September screening. A host of graphics are offered to assist fans to spread the word on social media. All contain the image of a driverless bus emerging from the mist in the dead of night. The film is being advertised with an unabashed call for donations. Or if you’d like to be an associate, co-‘ or executive producer with a minimum donation of $10,000, that privilege is a mere phone call away. No doubt Vaxxed III will make a profit for Kennedy’s CHD.

Of more concern, is that acceptance of COVID vaccine misinformation has grown in developed nations under the labour of anti-vaccine activists. The USA is currently experiencing a growth in the belief of COVID vaccine falsehoods and this film, along with the discussion that follows, may well worsen that trend in the US and elsewhere. Australian anti-vaxxers will have to wait for an online release.


Polly Tommey and Co discuss pre-release debunking of Vaxxed III