• medicine

Each encounter between a patient and clinician is likely to include an explicit or implicit evaluation of benefit versus risk and should always be an exercise in person-centred medicine. New stipulations from the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), a regulatory body representing European Union member states, about the use of valproate in women of childbearing potential1 bring these age-old considerations into sharp relief. There will be a change in the marketing authorisation: valproate will be contraindicated in pregnancy and women of childbearing potential not using effective contraception. This requires all clinicians who see people with epilepsy to think carefully again, even before changes to UK use of valproate are enforced by changes in the licence from the UK Medicines and Healthcare products Regulatory Agency (MHRA). The many challenges are brought out in two accompanying articles in this issue.2 3 Importantly, no one should stop valproate use abruptly because of this announcement, without consulting their doctor as doing so could result in harm to themselves or to an unborn child.

The background is well established and largely derived from prospective registries.4 Babies born to mothers who take valproate medicines during pregnancy have up to a 10% risk of birth defects, compared with 2%–3% background risk,5 and a variable, sometimes unknown, risk on polytherapy with other antiepileptic drugs.6 Some of these malformations may necessitate early corrective surgery; some are inoperable. There is an average reduction in IQ estimated at 6–11 points7 8 and 30%–40% risk of developmental disability.9–11 Compared with the general population, the risk of autism spectrum disorders is threefold and that of attention-deficit hyperactivity disorder is fivefold.12–14 These consequences may come with a lifetime burden of medical and social care for the family and the state. While some …