Kristi McDonald, a woman with epilepsy, has criticized the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for restricting the use of the anti-seizure medication Valproate. McDonald argues these restrictions, which require two specialists to approve its use for patients under 55, undermine patients’ informed consent and breach human rights. Valproate poses significant risks to unborn babies and male fertility, leading the MHRA to tighten its regulations since 2018, which many initially welcomed.
McDonald, who has taken Valproate for 40 years, insists that decisions about her medication should be hers alone. Meanwhile, Oxfordshire’s Health Overview and Scrutiny Committee has highlighted the negative impact of these rules on epilepsy services, urging a suspension of the restrictions pending review. The MHRA defends its stance, emphasizing the availability of alternative treatments and the necessity of mitigating known risks. However, critics say the policy exacerbates waiting lists and challenges for patients and clinicians alike.