Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if he will make an assessment of the possible link between the use of aspartame and seizures ahead of VimPat gaining approval by the European Commission.

In 2013, the European Food Safety Agency (EFSA) completed a comprehensive risk assessment of the safety of aspartame as a food additive and concluded that aspartame and its breakdown products are safe for human consumption, including pregnant women and children, at the current level of exposure. The EFSA panel agreed with previous opinion that the available data did not provide evidence for a relationship between aspartame consumption and enhanced susceptibility to seizures.

In April 2016, taking the EFSA review into account, the European Medicines Agency (EMA) published a draft of updated labelling guidance for products containing aspartame, which can be found at the EMA website below:

www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/05/WC500205999.pdf

There were no significant changes proposed to the current guidance on ‘Excipients in the label and package leaflet of medicines for human use’ (CPMP/463/00 Rev 1), which can be found at the EMA website below:

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003412.pdf

Vimpat (lacosamide), an antiepileptic drug, has been authorised in the European Union since 29 August 2008 and is currently approved as an add-on therapy to other antiepileptic medicines in the treatment of partial onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy. Vimpat syrup contains aspartame and this is declared in the product literature.

As with all medicines, after approval, the safety of the medicine is continuously monitored throughout their use in healthcare practice by pharmacovigilance activities. New safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously.