Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines containing paracetamol during pregnancy. In a recent statement, dated September 30, 2025, the agency maintained that the benefit-risk balance of these products remains positive. This announcement is important for clinical, quality, and regulatory professionals monitoring the safety profile of commonly used medications during pregnancy.
- What changed?
- What evidence supports this conclusion?
- FAQ
- Conclusion
- Disclaimer
- Swissmedic announcement
What changed?
The regulatory landscape regarding paracetamol usage during pregnancy remains stable following Swissmedic’s latest assessment. The agency carefully reviewed available evidence and concluded that paracetamol still presents a favorable benefit-risk profile in pregnant patients when used as advised.
Paracetamol is widely prescribed to manage mild to moderate pain and fever, and its safety during pregnancy has been continuously evaluated to ensure public health protection. No significant regulatory shifts or restrictions have been introduced at this time.
What evidence supports this conclusion?
Continuous monitoring of safety data
Swissmedic’s assessment relies on extensive post-market surveillance data, scientific studies, and clinical trials. These sources have consistently indicated that adverse effects associated with paracetamol use during pregnancy are rare when used as directed. Toxicological evaluations also support its safety under controlled use.
Risk mitigation strategies
To maximize safety, healthcare providers are encouraged to adhere to dosing recommendations and monitor patients closely. Paracetamol remains preferable over certain other analgesics due to its well-documented safety record.
Alignment with international standards
Swissmedic’s findings align with guidelines issued by other health authorities, such as the European Medicines Agency (EMA) and the World Health Organization (WHO), further reinforcing confidence in its conclusions.
FAQ
Q1. Is paracetamol safe for all trimesters?
Yes, provided it is used in recommended doses throughout pregnancy.
Q2. Are there any specific risks associated with paracetamol use during pregnancy?
When taken as directed, risks are minimal. Overuse or prolonged use may lead to complications.
Q3. Should pregnant individuals consult their doctors before using paracetamol?
Absolutely. Medical advice is essential when managing pain or fever during pregnancy.
Q4. How does Swissmedic ensure ongoing safety reviews?
Swissmedic continuously monitors data from clinical trials, epidemiological studies, and adverse event reports.
Conclusion
Swissmedic’s latest announcement underscores the safety and efficacy of paracetamol as an analgesic and antipyretic for pregnant individuals. Clinical, regulatory, and quality professionals should ensure compliance with dosing guidelines and facilitate communication between healthcare providers and patients to maintain trust and safety.
Disclaimer
This information is intended for professionals involved in clinical, regulatory, or quality sectors. It should not be regarded as legal advice. Always consult local regulations and healthcare professionals for specific guidance.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/stellungnahme-anwendung-paracetamol-haltigen-am.html