Paracetamol and Pregnancy Safety Debate among Regulators

Paracetamol, known as acetaminophen, is one of the most widely used painkillers and fever reducers worldwide. While the US and Japan use the name acetaminophen, Europe and most of the world call it paracetamol. However, paracetamol and pregnancy remain at the center of a new global discussion. While the drug is widely used as a safe option to relieve pain and fever, recent publications by regulatory authorities raise fresh questions about its safety in relation to autism.

Global regulatory authorities recently released statements on its safety, particularly concerning use during pregnancy. These publications highlight the importance of safety communication in pharmacovigilance and that scientific disagreement persists even with a common drug.

Why Safety Communication Matters

Communicating safety information to patients and healthcare professionals is a critical public health responsibility. It helps achieve the main goals of pharmacovigilance:

• Promoting rational, safe, and effective use of medicines.
• Preventing harm from adverse drug reactions.
• Protecting patients’ and public health.

When it comes to paracetamol and pregnancy, safety communication is essential. Pregnant women often need treatment for pain or fever, and paracetamol is usually the first choice. Pharmacovigilance ensures medicines are used rationally, safely, and effectively, protecting both mother and child.

The ongoing debate on paracetamol and its possible link to autism is a clear example of how differently regulators may interpret available evidence.

FDA: Concerns About Acetaminophen and Autism

The US Food and Drug Administration (FDA) took a strong stance in September 2025. Following a statement from the US President, the FDA announced plans for a label change for acetaminophen.

The agency cited evidence suggesting that acetaminophen use during pregnancy might be associated with an increased risk of autism and ADHD in children. Large-scale studies, such as the Nurses’ Health Study II and the Boston Birth Cohort, have reported this association, particularly with long-term use throughout pregnancy.

However, the FDA also noted that:

• A causal relationship has not been proven.
• Some studies contradict these findings.
• Acetaminophen remains the only OTC drug approved for fever treatment in pregnancy.
• Alternatives like aspirin and ibuprofen are known to harm the fetus.

EMA Guidance on Paracetamol and Pregnancy Unchanged

In contrast, the European Medicines Agency (EMA) has not introduced new restrictions. According to EMA’s Chief Medical Officer, Steffen Thirstrup:

“Paracetamol remains an important option to treat pain or fever in pregnant women. Our advice is based on a rigorous assessment of the available scientific data, and we have found no evidence that taking paracetamol during pregnancy causes autism in children.”

Key EMA points:

• Large amounts of pregnancy data show no risk of malformations.
• A 2019 review found studies on neurodevelopment inconclusive.
• Paracetamol can be used if needed, but always at the lowest effective dose for the shortest time.

EMA continues to monitor safety data and will update recommendations if new evidence emerges.

WHO Stance on Paracetamol and Pregnancy

The World Health Organization (WHO) emphasises that there is currently no conclusive evidence linking acetaminophen use during pregnancy to autism.

Key WHO notes:

• Around 62 million people worldwide live with autism spectrum disorder.
• Its causes remain multifactorial and not fully understood.
• Decades of research have found no consistent association.

WHO advises pregnant women to consult healthcare professionals before using any medication.

MHRA: Paracetamol Use Remains Safe

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also reaffirmed that paracetamol remains safe during pregnancy.

Their advice:

• Use paracetamol in line with existing NHS guidance.
• Untreated pain and fever can harm the baby, so treatment is essential.
• Pregnant women should discuss any concerns with their healthcare providers.

TGA: Strong Rejection of Autism Claims

The Therapeutic Goods Administration (TGA) in Australia strongly rejected claims linking paracetamol in pregnancy to autism or ADHD.

Highlights from TGA:

• No causal link has been established.
• Paracetamol remains Category A in pregnancy—considered safe when used correctly.
• Several robust studies refute autism claims.
• Untreated fever and pain are dangerous and require treatment.
• Safety surveillance in Australia remains ongoing, with rapid regulatory action if new risks appear.

Paracetamol and Pregnancy Regulatory Opinions Divided

The debate around paracetamol and autism shows how scientific interpretation can vary between regulatory authorities.

• The FDA is moving towards stricter labelling.
• The EMA, WHO, MHRA, and TGA continue to support its use, with no new restrictions.

For now, the advice is clear: pregnant women should always seek medical advice before using any medicine. While research continues, paracetamol remains the preferred treatment option for pain and fever during pregnancy worldwide.