Official Statement Addresses Public Concerns About Acetaminophen Use During Pregnancy
Kenya’s Pharmacy and Poisons Board has issued an official press statement reassuring the public about the safety of paracetamol use during pregnancy. The regulatory authority confirmed that paracetamol, also known as acetaminophen, remains a recommended medicine for pain and fever relief in pregnant women when taken as directed by qualified healthcare professionals.
The statement, released on October 2, 2025, by Acting Chief Executive Officer Dr. Ahmed I. Mohamed, comes amid growing public concerns about potential links between paracetamol use during pregnancy and developmental conditions in children. The Board emphasized that there is no conclusive scientific evidence confirming these associations.
About the Pharmacy and Poisons Board
The Pharmacy and Poisons Board is Kenya’s National Medicines Regulatory Authority, established under the Pharmacy and Poisons Act, CAP 244. The institution serves as the country’s primary watchdog for pharmaceutical safety and quality control.
The Board’s mandate encompasses safeguarding the safety, quality, and efficacy of health products and technologies distributed and used within Kenya. Additionally, the authority is responsible for providing the public with accurate, science-based information to support the safe and rational use of medicines.
As the national regulatory body, the PPB works closely with healthcare providers, pharmaceutical manufacturers, importers, and distributors to ensure that medicines available in the Kenyan market meet international safety standards. The organization also collaborates with international regulatory agencies and the World Health Organization on matters of pharmaceutical safety.
Background on Paracetamol Use
Paracetamol stands as one of the most widely used medicines in Kenya and globally. The medication is commonly prescribed for pain relief and fever reduction, making it a staple in both household medicine cabinets and healthcare facilities across the country.
The drug’s popularity stems from its effectiveness, relatively low cost, and general safety profile when used according to recommended dosages. Paracetamol is available over-the-counter in various formulations, including tablets, capsules, syrups, and suppositories, making it accessible to diverse patient populations.
For pregnant women, paracetamol has historically been considered the preferred option for managing pain and fever due to its established safety record. Healthcare providers routinely recommend it for conditions ranging from headaches and body aches to fever associated with infections during pregnancy.
Addressing Recent Concerns
The Board’s statement acknowledges that some studies have suggested possible links between paracetamol use during pregnancy and conditions such as autism spectrum disorder (ASD) or attention deficit hyperactivity disorder (ADHD) in children. These studies have generated considerable public concern and media attention in recent months.
However, the PPB emphasized that there is no conclusive scientific evidence confirming these associations. The Board noted that correlation does not necessarily indicate causation, and that multiple factors influence child development and the occurrence of neurodevelopmental conditions.
The regulatory authority’s Pharmacovigilance Division, which monitors the safety of medicines used in Kenya, has not received any reports linking paracetamol use in pregnancy to ASD or ADHD. This absence of local adverse event reports further supports the Board’s position on the medication’s safety profile.
Official Guidelines for Paracetamol Use During Pregnancy
The Pharmacy and Poisons Board issued comprehensive public guidelines for the appropriate use of paracetamol during pregnancy. These guidelines emphasize a cautious, medically supervised approach to medication use.
The first guideline stresses that paracetamol should be used only when necessary. Pregnant women should take the medication only when needed, at the correct dose and duration, and strictly under the prescription of a qualified healthcare provider. This approach ensures that medication use is justified and properly monitored.
The second guideline warns against self-medication. The Board explicitly stated that pregnant women should not take any medicine, including paracetamol, without the guidance of a qualified health professional. Self-medication during pregnancy carries risks that extend beyond the medication itself, including incorrect dosing, inappropriate duration of use, and failure to identify underlying conditions requiring different treatment.
The third guideline encourages professional counseling. Healthcare providers are urged to counsel pregnant women on the safe and appropriate use of paracetamol and other medicines during pregnancy. This counseling should include information about proper dosing, timing, duration of use, and circumstances under which medical attention should be sought.
The Role of Pharmacovigilance
The PPB’s Pharmacovigilance Division continues to monitor the safety of medicines used during pregnancy to protect the health of mothers and children. Pharmacovigilance refers to the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other medicine-related problems.
This continuous monitoring system allows the Board to identify potential safety signals and take appropriate regulatory action when necessary. The Division analyzes reports from healthcare providers, patients, and pharmaceutical companies to identify patterns that might indicate safety concerns.
The Board reaffirmed its commitment to safeguarding public health through continuous monitoring of medicine safety, including those used during pregnancy. The authority pledged to provide timely updates as necessary should new evidence emerge regarding paracetamol or any other medication.
Reporting Systems for Adverse Effects
The Pharmacy and Poisons Board encourages healthcare professionals and members of the public to report any suspected side effects from medicines, including paracetamol. The authority has established multiple channels for reporting to make the process accessible and convenient.
Reports can be submitted through the Pharmacovigilance electronic reporting system available at https://pv.pharmacyboardkenya.org/. This online platform allows for detailed reporting of adverse drug reactions and provides a structured format for documenting relevant information.
The MPvERS mobile application, available on both the App Store and Google Play Store, offers another convenient reporting option. This mobile-first approach recognizes that many Kenyans access digital services primarily through smartphones.
Traditional reporting channels remain available as well. Concerned individuals can call the Board directly at 0795 743 049 or send an email to pv@ppb.go.ke. For self-reporting by members of the public, a dedicated hotline is available by dialing *271#.
Implications for Pregnant Women and Healthcare Providers
The Board’s statement provides important clarity for pregnant women who may have been concerned about using paracetamol for pain or fever management. The reassurance from the national regulatory authority allows expectant mothers to make informed decisions in consultation with their healthcare providers.
For healthcare providers, the statement reinforces the appropriateness of prescribing paracetamol for pregnant patients when clinically indicated. However, it also emphasizes the importance of proper counseling and monitoring to ensure safe use.
The guidelines underscore the principle that all medication use during pregnancy should be judicious and medically supervised. Even medications with well-established safety profiles should not be used casually or without professional guidance during this critical period.
Balancing Risk and Benefit in Pregnancy
The PPB’s statement reflects a fundamental principle in medical care during pregnancy: the need to balance potential risks against clear benefits. Untreated pain and fever during pregnancy can themselves pose risks to both mother and developing baby.
High fever during pregnancy has been associated with adverse outcomes including neural tube defects and other developmental issues. Similarly, severe pain can affect maternal wellbeing, sleep, nutrition, and overall health. These considerations must be weighed against theoretical or unproven risks associated with medication use.
The Board’s position recognizes that completely avoiding all medication during pregnancy is neither practical nor always in the best interest of maternal and fetal health. Instead, the focus should be on informed, supervised use of medications with established safety profiles when medically necessary.
International Perspective on Paracetamol Safety
Kenya’s position aligns with guidance from major international regulatory agencies and health organizations. The World Health Organization includes paracetamol on its List of Essential Medicines, recognizing its importance in healthcare systems globally.
Major regulatory authorities in other countries, including the United States Food and Drug Administration and the European Medicines Agency, continue to consider paracetamol appropriate for use during pregnancy when taken as directed. While these agencies acknowledge ongoing research into potential associations with developmental conditions, they maintain that current evidence supports continued use under medical supervision.
This international consensus provides additional context for the PPB’s position and demonstrates that Kenya’s regulatory approach is consistent with global standards for pharmaceutical safety assessment.
Public Health Communication
The Board’s proactive communication on this issue demonstrates the importance of clear, science-based public health messaging. In an era of widespread misinformation and health anxiety amplified by social media, authoritative statements from regulatory agencies help the public make informed decisions.
The statement also illustrates the PPB’s responsiveness to public concerns. By addressing questions about paracetamol safety directly and providing clear guidelines, the Board fulfills its mandate to provide accurate information supporting safe medicine use.
Healthcare providers play a crucial role in translating this regulatory guidance into practice. The Board’s encouragement for providers to counsel pregnant women reflects recognition that effective communication between healthcare professionals and patients is essential for optimal outcomes.https://x.com/amerix/status/1973716270705996168?t=298qzweheBXVnefl5CZXBA&s=19
Conclusion
The Pharmacy and Poisons Board’s statement on paracetamol safety during pregnancy provides important reassurance while emphasizing the principles of cautious, supervised medication use. Paracetamol remains a recommended option for pain and fever relief in pregnant women when used appropriately under professional guidance.
The absence of conclusive evidence linking paracetamol to developmental conditions, combined with the medication’s established benefits and decades of clinical experience, supports its continued use during pregnancy. However, the Board’s guidelines remind expectant mothers that all medication use should be necessary, properly dosed, and medically supervised.
As research continues into medication safety during pregnancy, regulatory authorities like the PPB will continue monitoring evidence and updating guidance as needed. Pregnant women experiencing pain or fever should consult healthcare providers to determine the most appropriate treatment approach for their individual circumstances.
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