The British Pharmacological Society (BPS) has published a new position statement highlighting the urgent need for clearer, evidence-based guidance on the use of medicines during pregnancy and breastfeeding. The statement draws attention to significant evidence gaps, inconsistent advice for patients, and the longstanding exclusion of pregnant and breastfeeding women from clinical trials.
More than 80% of women in the UK take at least one medication during pregnancy or breastfeeding, yet limited safety and efficacy data often lead to uncertainty, anxiety, and avoidable changes to essential treatment. The Society stresses that maintaining good control of maternal health conditions is crucial for the wellbeing of both mother and child.
The statement also reflects experiences captured through initiatives such as the WRISK Project, which show how unclear guidance can leave women feeling unsupported and at risk of poorer health outcomes. Physiological changes during pregnancy, combined with limited research, mean that both undertreated illness and unnecessary avoidance of medicines can carry significant risks.
The BPS is calling for a major shift in clinical trial design to ensure pregnant and breastfeeding women are no longer excluded, and highlights advances in pharmacokinetic modelling, preclinical testing and real world evidence that now support safer and more inclusive research. The Society also urges improvements in risk communication, with positively framed, accessible information to help women and clinicians make informed decisions.
Professor Cherry Wainwright, President, British Pharmacological Society, said:
The BPS has released this statement because the current landscape leaves too many pregnant women navigating treatment without the clear, evidence based guidance they deserve. Our review shows that decades of excluding pregnant women from clinical research have created avoidable gaps in safety data, leading to uncertainty, delayed treatment, or unnecessary discontinuation of essential medicines. By publishing this statement, we are calling for a fundamental shift, to ensure research, regulation, and clinical practice finally reflect the needs of pregnant women, so they can make informed decisions with confidence.
Professor Catriona Waitt said:
Women need access to evidence that truly reflects their circumstances. The absence of data leads to vague prescribing guidance. This can be harmful, pushing women toward unnecessary risk from medications which might be older or less effective or untreated illness, often compounded by considerable anxiety about their health and treatment. Improving research, communication, and clinical confidence will help ensure that every pregnant and breastfeeding woman receives the right treatment, at the right time, with the right information.
Dr Anita Banerjee said:
Unclear or inconsistent advice can leave many women feeling anxious about using medicines during pregnancy. As clinicians, we see the consequences when people stop or avoid treatment because they don’t feel adequately informed. This begins even before pregnancy. Effective preconception counselling provides a vital opportunity to support women with balanced, evidence-based information so they can enter pregnancy and breastfeeding with confidence rather than concern. Clear communication at every stage, rooted in robust and accessible guidance, is essential for safe, timely decision-making. This initiative strengthens that commitment and empowers women to make informed choices with trust and reassurance.
Dr Emma Magavern said:
Pregnant and breastfeeding women have been systematically underserved by medicines research and policy. A step change in policy, investment, and professional education is urgently needed to generate robust evidence on the safe and effective use of medicines during pregnancy and lactation and to communicate existing evidence clearly to clinicians and patients. Current practice often focuses disproportionately on the potential harms of medicines while overlooking the significant risks of withholding or discontinuing appropriate treatment. Ensuring balanced, evidence-based decision-making is essential to protect the health of both women and their children.
