Pregnant and breastfeeding women should be included in clinical trials, experts urge
Pregnant and breastfeeding women should be included in clinical trials, experts urge

Experts are calling for urgent action to better protect pregnant women and new mothers, advocating for their inclusion in clinical trials to ensure safe access to vital medicines. The British Pharmacological Society (BPS) has highlighted that four in five women in the UK take at least one medication during pregnancy or breastfeeding, yet have historically been excluded from such trials, leading to significant gaps in safety and efficacy data.

In a new position statement, the BPS emphasises the need for clearer, evidence-based guidance on medication use during pregnancy and lactation. The current lack of information often leaves women making critical decisions without adequate evidence, with advice disproportionately focusing on risks rather than benefits. This uncertainty can lead to fear, inconsistent advice, and sometimes unnecessary discontinuation of essential medicines.

Professor Cherry Wainwright, president of the BPS, said: “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.” Professor Catriona Waitt from the University of Liverpool added: “Rather than protecting women from research, we should protect them through research.” She noted that without data, women may avoid needed medication or stop breastfeeding unnecessarily.

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Dr Emma Magavern from Queen Mary University of London pointed out that risk-benefit communication is often skewed, with potential harm to the foetus overemphasised compared to the risks of untreated disease. The BPS recommends more inclusive research, balanced information, and better training for healthcare staff to address these issues.

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