之间 September 23–26, 2025, multiple health authorities, including Singapore’s Health Sciences Authority (HSA), Australia’s 治疗用品管理局（TGA）, France’s ANSM, Chile’s ISP, Switzerland’s Swissmedic, Portugal’s Infarmed, Spain’s AEMPS, Belgium’s AFMPS/EMA, Thailand’s FDA， 和 New Zealand’s Ministry of Health (MOH) issued coordinated advisories reaffirming the safety of paracetamol (acetaminophen) use during pregnancy.
While these advisories address ongoing public debate about possible links between prenatal paracetamol exposure and 神经发育障碍 such as autism spectrum disorder (ASD) 和 attention-deficit/hyperactivity disorder (ADHD), all regulators except Chile’s ISP concluded that current scientific evidence does not support a causal relationship.
Regulatory Updates by Country
Singapore (HSA): Published on September 26, 2025, the HSA advisory stated that no established evidence links paracetamol uses in pregnancy to autism or other neurological conditions in children. Paracetamol remains recommended for managing pain and fever when clinically necessary. HSA continues post-market safety monitoring and international collaboration to review emerging data.
Australia (TGA): 在 September 23, 2025, the TGA reaffirmed paracetamol’s Pregnancy Category A classification, indicating it is safe when used as directed. No causal link was found between prenatal use and autism or ADHD. The TGA emphasized managing maternal fever and pain as critical to fetal health and continues ongoing pharmacovigilance.
France (ANSM): Issued on 2025年9月25日, ANSM confirmed that paracetamol remains the safest analgesic and antipyretic during pregnancy, with NSAIDs contraindicated after the sixth month due to fetal risk. The agency reiterated the absence of evidence linking paracetamol to neurological disorders.
Chile (ISP): 在 September 23, 2025, ISP issued a more cautious advisory, acknowledging inconclusive findings suggesting a possible association between paracetamol use during pregnancy and neurodevelopmental disorders. The ISP noted regulatory divergence, as FDA considers label updates while EMA 和 AEMPS have not revised guidance. The agency continues its review of global literature and recommends medical supervision.
Switzerland (Swissmedic): Published on September 24, 2025, the Swissmedic advisory aligned with global consensus, confirming no proven link between paracetamol and autism. Paracetamol remains authorized for use during pregnancy, provided it follows package leaflet guidance.
Portugal (Infarmed): 在 September 23, 2025, Infarmed confirmed no changes to paracetamol’s safety profile, following EMA’s review. It remains approved for clinical use in pregnancy, with emphasis on minimal effective doses and duration.
Spain (AEMPS): Also dated September 23, 2025, AEMPS reaffirmed that no causal relationship exists between paracetamol and autism or neurodevelopmental disorders. Recommendations on dosage and duration remain unchanged.
Belgium and EMA (AFMPS/EMA): Issued jointly on September 23, 2025, the advisory reconfirmed that paracetamol remains the first-choice treatment for pain and fever in pregnancy, citing large-scale studies showing no link to ASD or ADHD. Surveillance on long-term safety will continue.
Thailand (FDA): On September 25 2025, Thailand’s FDA clarified that no clear evidence supports claims connecting paracetamol use during pregnancy to autism. Paracetamol remains the first-choice medication for pain and fever in pregnant women when used responsibly. The FDA referenced a 2024 Swedish study and global reviews by the U.S. FDA, UK MHRA, and EU EMA, emphasizing lowest effective dose, shortest duration, and professional consultation.
New Zealand (MOH / Medsafe): Published September 26 2025, the MOH reaffirmed that paracetamol is the safest option for treating pain and fever during pregnancy, with no causal link to autism based on high-quality scientific data. Medsafe continues ongoing pharmacovigilance and encourages consultation with healthcare professionals for medication guidance.
为什么重要
These consistent advisories across global regulators reinforce regulatory alignment on paracetamol’s safety profile during pregnancy. By maintaining current recommendations, regulators ensure clarity and continuity for healthcare professionals and pharmaceutical manufacturers while minimizing confusion for consumers.
This coordinated communication also underscores the importance of evidence-based pharmacovigilance, reducing unnecessary regulatory burden and maintaining public confidence in widely used over-the-counter medications.
Who This Update Is Relevant For
These consistent advisories across global regulators reinforce regulatory alignment on paracetamol’s safety profile during pregnancy. By maintaining current recommendations, regulators ensure clarity and continuity for healthcare professionals and pharmaceutical manufacturers while minimizing confusion for consumers.
This coordinated communication also underscores the importance of evidence-based pharmacovigilance, reducing unnecessary regulatory burden and maintaining public confidence in widely used over-the-counter medications.
Next Steps for Stakeholders
Regulatory and labeling teams should:
- Review Product Information (PI), Consumer Medicine Information (CMI), and package leaflets for consistency with updated national guidance.
- Continue monitoring advisories from FDA, EMA, ISP, and other agencies for any emerging data that could affect labeling or risk communication.
- Align marketing and patient education materials with current recommendations on dosage, duration, and medical consultation requirements.
As regulatory scrutiny around maternal health and safety grows, proactive monitoring and document alignment will be key to maintaining compliance.
To help organizations stay ahead of evolving global updates, RegASK provides AI-driven solutions and expert support that track, analyze, and operationalize such regulatory advisories across jurisdictions.
RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely, predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 140 countries. 了解更多 或者 立即预订演示。
常见问题解答
What is the current global regulatory position on paracetamol use during pregnancy?
Regulators in Singapore, Australia, France, Switzerland, Portugal, Spain, Belgium, the UK,and the EU have confirmed that paracetamol remains safe for use during pregnancy when clinically necessary, with no proven link to autism or ADHD.
Which countries have expressed caution regarding paracetamol and neurodevelopmental disorders?
Chile’s ISP has urged careful use pending further review, citing inconclusive findings, while the U.S. FDA is considering label updates to reflect ongoing scientific debate.
Why are NSAIDs contraindicated during pregnancy?
According to France’s ANSM, NSAIDs such as ibuprofen, ketoprofen, and aspirin are contraindicated after the sixth month of pregnancy due to severe fetal risks, making paracetamol the preferred alternative.
How can RegASK help regulatory teams manage evolving drug safety advisories?
RegASK enables pharmaceutical and healthcare organizations to track global regulatory updates, evaluate impact, and automate compliance workflows ensuring product information, labeling, and communication remain aligned across jurisdictions.
