01 November 2009
Vigabatrin is a medicine used to treat epilepsy and infantile spasms or West’s syndrome (epilepsy in infants).
This report summarises a European review of information from clinical trials, published literature and adverse drug reaction case reports for vigabatrin.
The review concluded that there is a risk of movement disorders (abnormal body movements) and abnormalities in magnetic resonance imaging (MRI) scans of the brain with vigabatrin use. Product information for vigabatrin will be updated with warnings on these risks.
This safety issue has also been highlighted in the November 2009 issue of Drug Safety Update (page 4) (225Kb).
This report presents the evidence that was available when the regulatory decision was made, showing a ‘snapshot’ of the clinical landscape at the time. However, any advice in this report remains current unless it is superseded by a more recent report (where relevant, this is indicated).