Epilepsy and other seizure disorders

Drug Safety Update

June 2025: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): updated safety and educational materials to support patient discussion on reproductive risks

 February 2025: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate

 September 2024: Valproate use in men: as a precaution, men and their partners should use effective contraception

June 2024: Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme

January 2024: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age

October 2023: Valproate: dispense full packs of valproate-containing medicines

August 2023: Valproate: re-analysis of study on risks in children of men taking valproate

December 2022: Valproate: reminder of current Pregnancy Prevention Programme requirements; information on new safety measures to be introduced in the coming months

July 2022: Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure

April 2022: Pregabalin (Lyrica): findings of safety study on risks during pregnancy

February 2021: Pregabalin (Lyrica): reports of severe respiratory depression

January 2021: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

 April 2019: Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

 April 2019: Pregabalin (Lyrica), gabapentin (Neurontin) and risk of abuse and dependence: new scheduling requirements from 1 April

 March 2019: Medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed?

 December 2018:Valproate medicines: are you acting in compliance with the pregnancy prevention measures?

 September 2018: Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

April 2018: Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met

November 2017: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

  October 2017: Gabapentin (Neurontin): risk of severe respiratory depression

 November 2016: Patient Safety Alert: Risk of death or severe harm from error with injectable phenytoin

 December 2012: Carbamazepine, oxcarbazepine and eslicarbazepine potential risk of serious skin reactions

 April 2009: Antiepileptics adverse effects on bone (carbamazepine, phenytoin, primidone and sodium valproate)

 August 2008: Antiepileptics risk of suicidal thoughts and behaviour

April 2008: Carbamazepine: genetic testing recommended in some Asian populations

• Higher risk of carbamazepine-induced Stevens -Johnson syndrome in some Asian populations. Also see December 2012 update above

 November 2007: Herbal ingredient St John's Wort may interact with antiepileptics

• This should not be taken concurrently.