Epilepsy Drug Restrictions Spark Human Rights Concerns

Kristi McDonald, an individual with epilepsy residing in Southmoor, Oxfordshire, has leveled an accusation against the UK’s drug safety authority, alleging a failure to adequately serve patients. She stated that the Medicines and Healthcare products Regulatory Agency’s (MHRA) guidelines concerning the anti-seizure drug Valproate are inconsistent with the NHS’s foundational principles of informed consent. Under current regulations, Valproate prescriptions are prohibited for individuals with epilepsy, both women and men, who are under 55 years old, unless its suitability as the optimal treatment is affirmed by two distinct medical specialists. An MHRA spokesperson indicated that the new measures were implemented to mitigate the documented risks associated with valproate, specifically mentioning “including the significant risk of serious harm to the baby if taken during pregnancy.” Estimates suggest that thousands of children in the UK have suffered harm due to prenatal exposure to sodium valproate since the 1970s. The MHRA initially introduced restrictions in 2018, and the latest safety update received positive reception from numerous campaigners upon its implementation. However, Ms McDonald, who has been taking Valproate for four decades, asserted: “It’s my choice as a patient to make a decision regarding the medication that I take. “What the MHRA has done [with the restrictions] is systemically strip that away from women under the age of 55.” Ms McDonald, who has experienced photosensitive epilepsy for 40 years, expressed her conviction that these measures now violate human rights law, stating her belief that everyone should have the right to choose: “It’s my body, it’s my decision. It’s not theirs”. Earlier in the current month, the Oxfordshire Health Overview and Scrutiny Committee, part of Oxfordshire County Council, communicated with Healthcare Minister Karin Smyth, cautioning about a ‘dire situation’ concerning epilepsy services within Oxfordshire. The committee’s chair, Liberal Democrat county councillor Jane Hanna, who is also the founder of the epilepsy charity SUDEP Action, stated that the MHRA’s policy was significantly affecting epilepsy waiting lists in the region. She further noted that the well-being of epilepsy clinicians and the safety of patients reliant on Valproate were also being affected. Her written communication emphasized that “urgent action” from the NHS was necessary to bolster local epilepsy services in the county, and she implored the minister to temporarily halt the MHRA’s latest updates to the restrictions until an independent review could be conducted. Dr. Alison Cave, the MHRA’s chief safety officer, explained that the Commission on Human Medicines (CHM) had advised the implementation of new regulatory measures to mitigate the documented risks associated with valproate, specifying “including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.“For the majority of patients there are other effective authorised medicines for epilepsy and bipolar disorder available. However, it remains a treatment option for those for whom it is the only effective treatment.” Readers can find BBC Oxfordshire on social media platforms such as Facebook, X (formerly Twitter), or Instagram. This article is copyrighted by the BBC in 2024, with all rights reserved. The BBC disclaims responsibility for content found on external websites and provides information regarding its policy on external linking.