What We Know and Don’t Know About the Connection Between Painkillers and Autism

The US government raised concerns about painkillers used during pregnancy

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On Monday, the US government introduced two initiatives concerning autism. One update involves labeling for paracetamol, commonly known as acetaminophen, emphasizing that its use during pregnancy could elevate the risks of autism and ADHD in children. The government also approved leucovorin for certain children diagnosed with autism spectrum disorder (ASD). However, these actions are not strongly supported by scientific evidence and may have negligible effects on autism prevalence in the United States.

This announcement followed Robert F. Kennedy Jr.’s pledge, made in April, to uncover the causes of autism by the close of September. President Donald Trump later described this initiative at a press conference as “a historic step towards battling the autism crisis.”

This portrayal indicates a possible misunderstanding or distortion of existing knowledge about autism. There is no crisis as such. Autism rates began to surge rapidly since the 1980s, significantly influenced by increased awareness and recognition of its symptoms leading to more frequent diagnoses.

Evidence supporting the idea that paracetamol causes autism is limited. While several studies indicate a correlation between paracetamol use during pregnancy and an elevated risk of autism in children, causation should not be assumed. A recent investigation involving 46 studies found that 27 of them reported a significant link between paracetamol use in pregnancy and heightened risk for neurodevelopmental issues, including autism. Nevertheless, correlation does not imply causation; other underlying factors may also play a role.

Contrasting findings are evident in other studies. For instance, a 2024 evaluation analyzing around 2.5 million children determined that while those exposed to paracetamol during pregnancy faced a marginally higher autism risk, this effect diminished when comparing children exposed to painkillers with their siblings. “It wasn’t the paracetamol use, but rather family history that played a crucial role,” said Dimitrios Siasacos from University College London. “Although studies indicate a slight increase in autism outcomes related to paracetamol use during pregnancy, this tends to vanish when analyzing the more significant factors involved.”

During a press briefing, Trump advised that pregnant women should avoid taking paracetamol for pain or fever. However, the US Food and Drug Administration (FDA) issued a press release stating that no causal link between paracetamol and autism has been established. Additionally, in a notification to healthcare providers, the FDA confirmed that paracetamol remains the safest and most accessible pain relief option during pregnancy. “[It] is the only over-the-counter medication that is approved for use to treat fever during pregnancy, as a high fever can pose risks to the developing fetus,” emphasizing potential fetal brain or spinal cord defects.

The FDA also announced its approval of leucovorin for individuals with cerebral folate deficiency, a condition that affects the brain’s capability to absorb vitamin B9. Studies suggest that around 40% of people with autism may be affected by this deficiency, leading to similar symptoms, including difficulties with communication and sensory processing.

Leucovorin, a form of vitamin B9, is already utilized to address deficiencies of this vitamin and to mitigate side effects from certain cancer treatments. Preliminary evidence implies that it might aid in alleviating severe autism symptoms. For instance, a 2016 study involving 25 autistic children treated with leucovorin demonstrated that 65% showed meaningful improvements in verbal communication skills compared to only 24% in the placebo group after 12 weeks.

However, existing studies on leucovorin and autism have been relatively small, often yielding only modest positive results. Larger clinical trials are in progress, with results expected next year. “Currently available evidence is tentative and not yet deemed comprehensive,” stated Monique Botha at Durham University. “While these medications might offer benefits in specific areas, there are no treatments that effectively address or eliminate autism as a whole.”

Following the announcement, the U.S. Department of Health and Human Services reiterated that “while promising, it’s crucial to understand that leucovorin is not a cure for ASD but may help to enhance speech-related skills in a limited group of children with the condition.”

With Trump’s backing, Kennedy is positioning the “autism epidemic” as a cornerstone of U.S. public health policy. They are both framing these policy developments as substantial milestones achieved in a brief timeframe. However, scientific evidence suggests that avoiding paracetamol during pregnancy or utilizing leucovorin is unlikely to have the significant impact on autism that Trump and Kennedy claim. Instead, the most probable outcome of these initiatives pertains to how and when to manage pain and fever safely during pregnancy.

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Source: www.newscientist.com

Common Painkillers During Pregnancy Linked to Increased Risk of ADHD in Children

Microscopic view of paracetamol crystals

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Children who used paracetamol, also known as acetaminophen, during their mother’s pregnancy, are more likely to develop ADHD than those whose mothers do not, suggesting small studies. Although inconclusive, this finding gives weight to the contested idea that widely used painkillers can affect fetal brain development.

Previous studies on paracetamol and neurodevelopmental conditions provide conflicting findings. For example, a 2019 study linking over 4,700 children and their mothers with their mothers to use painkillers during pregnancy There is a 20% higher risk Children developing ADHD. However, the analysis presented by nearly 2.5 million children last year There is no such connection When comparing siblings who were exposed or not to paracetamol before birth.

One problem is that most of these studies rely on self-reported medication use. This is a serious limitation as you may not remember taking paracetamol during pregnancy. For example, only 7% of participants in the 2019 study reported using paracetamol during pregnancy. It's well below the 50% seen in other studies. “A lot of people take it [paracetamol] Without knowing that” Brennan Baker At Washington University in Seattle. “It could be the active ingredient in some of the cold medicines you're using, and you don't necessarily know.”

So Baker and his colleagues used more accurate metrics instead. They looked for medication markers in blood samples collected from 307 women. They were all black and lived in Tennessee in the late pregnancy. None of them were taking medication due to chronic illnesses and were unaware of the complications of pregnancy. The researchers then followed up with participants when the child was 8 to 10 years old. In the US, Approximately 8% of children I have ADHD between the ages of 5 and 11.

On average, children whose mothers had a marker of paracetamol in their blood were three times more likely than children born to mothers, even after adjusting for factors such as mother's age and body mass index before pregnancy. There was a possibility (BMI), mental health status among close relatives of socioeconomic status and mental health. This suggests that using paracetamol during pregnancy may increase the risk of developing ADHD in children.

However, it is also possible that the actual factor that increases your risk of ADHD is not the drug itself, but the first thing you will be taking paracetamol. “They couldn't explain anything like the reason why their mother took it. [paracetamol]”It has been found to be risk factors for adverse development in children, such as headaches, fever, pain and infectious diseases.” Viktor Ahlqvist At the Karolinska Institute in Sweden.

But Baker believes that it is the drugs that are responsible. Subsequent analysis of tissue samples from 174 of participants' placenta showed that people using paracetamol have different metabolic and immune system changes. These changes are similar to those seen in studies testing the effects of paracetamol in pregnant animals without infection or underlying health conditions.

“I think the fact that we see immune upregulation in animal models also really strengthens the causal case,” Baker says. “There are many previous studies showing that elevated immune activation during pregnancy is linked to adverse neurodevelopment.”

Yet these findings are far from conclusive. For one thing, the study included a small number of participants, all black and lived in the same city, limiting the generalization of the findings. Another case, it measured only the blood markers of paracetamol at one moment. These markers have stuck for about three days, so the study probably captured more frequent users, and may have a dose-dependent effect, says Baker.

“[Paracetamol] Now is the first-line treatment option for pain and fever during pregnancy,” says Baker. “But I think I'm an agency [US Food and Drug Administration] In addition, various obstetric and gynecological associations should continuously review all available research and update their guidance. ”

Meanwhile, if it's unclear whether to take paracetamol during pregnancy, people should talk to their doctor, Baker says.

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Source: www.newscientist.com

Combining Over-the-Counter Painkillers with Birth Control Raises Blood Clot Risk

A new study has found that women using NSAIDs with hormonal contraceptives, especially high-risk types and those using diclofenac, have an increased risk of blood clots. This study calls for increased awareness and careful consideration of safer pain relief and contraceptive options.

Researchers advise that while the absolute risk remains low, women should be informed accordingly.

People using nonsteroidal anti-inflammatory painkillers in combination with hormonal contraceptives may be at a slightly higher risk of venous thromboembolism (VTE), according to a recently published comprehensive Danish study. There is a gender. BMJ.

The risk was higher for women using combination oral contraceptives containing third- or fourth-generation progestins, but the nonsteroidal anti-inflammatory drugs (NSAIDs) ibuprofen, diclofenac, and progestin-only tablets; Women with implants and coils had a smaller risk. Naproxen.

Researchers stress that the absolute risk of developing serious blood clots is low, even for women using high-risk hormonal contraceptive methods. However, they say that given the widespread use of both hormonal contraceptives and NSAIDs, women should be informed of this potential drug interaction in a timely manner.

Classification of hormonal contraception and NSAID use

Although NSAIDs have been linked to blood clots, little is known about whether their use affects the risk of venous thromboembolism in healthy women using hormonal contraceptives. not.

To address this, the researchers used national medical records to find 49 children aged 15 to 49 with no history of blood clots, cancer, hysterectomy, or infertility treatment living in Denmark between 1996 and 2017. Two million women aged 20-30 years were tracked for their first diagnosis of venous thromboembolism.

Hormonal contraception was classified as high-risk, intermediate-risk, and low-risk according to its association with VTE based on previous studies.

High-risk hormonal contraception includes patches that combine estrogen and progestin, vaginal rings, and tablets containing 50 mcg of estrogen or third- or fourth-generation progestins. Moderate-risk contraception includes all other combination oral contraceptives and medroxyprogesterone injections, but progestin-only pills, implants, and hormonal intrauterine devices (coils) are classified as low-risk or no risk. I did.

Various potentially influencing factors were also taken into account, including age, education level, pregnancy history, previous surgical history, hypertension, and diabetes.

In this study, 529,704 women using hormonal contraceptives used NSAIDs. The most frequently used NSAID was ibuprofen (60%), followed by diclofenac (20%) and naproxen (6%).

Over an average 10-year monitoring period, 8,710 cases of venous thromboembolism (2,715 pulmonary embolisms and 5,995 deep vein thromboses) occurred, and 228 (2.6%) women died within 30 days of diagnosis.

Meaning and recommendations

In absolute terms, NSAID use is associated with 4 additional venous thromboembolic events per week per 100,000 women not using hormonal contraception and using intermediate-risk hormonal contraception. It was associated with 11 additional events in women and 23 additional events in women using high-risk hormonal contraception.

Among individual NSAIDs, diclofenac had the strongest association compared with ibuprofen and naproxen.

Because this is an observational study, it is not possible to determine cause, and the researchers highlight several limitations, such as missing information on smoking and obesity, which may influence the results. It is said that there is a possibility that

Nevertheless, this was a large study based on high-quality registry data, allowing the researchers to adjust for a wide range of potentially influencing factors. Furthermore, the associations persisted after further analysis, suggesting that they are robust.

Therefore, the researchers concluded that: “By using high-quality, linkable national registries, this national study shows that potentially fatal events occur when two drugs commonly prescribed to healthy women are taken together. It adds new knowledge about the risks involved.”

They added: “Women who require both hormonal contraception and regular use of NSAIDs should be advised accordingly.”

These data raise important concerns about the combined use of NSAIDs, particularly diclofenac, and high-risk hormonal contraceptives, writes Morten Schmidt. Aarhus University Hospital, linked editorial.

She said health authorities and regulators should include these findings in safety assessments of over-the-counter diclofenac, and that women using hormonal contraceptives and their clinicians should consider alternatives to NSAIDs for pain relief. I suggest that you should.

“If treatment with an NSAID is necessary, it may be preferable to use drugs other than diclofenac in conjunction with low-risk hormonal contraceptives, such as progestin-only tablets, implants, or intrauterine devices.” He concludes.

This study was funded by the Danish Heart Foundation.

Source: scitechdaily.com