§ Mr. LockTo ask the Secretary of State for Health (1) how many deaths have been reported to his Department since the drug, Lamotrigine, has been licensed for use in Britain arising out of or related to the use of this drug or arising out of or connected to side effects suspected to be related to the use of this drug; [67007]
(2) pursuant to his answer of 30 March 1999, Official Report, columns 656–57, on Lamotrigine, how many suspected deaths have been reported to his Department or the Medicines Control Agency arising out of or related to Lamotrigine. [80230]
424W
§ Mr. Denham[holding answer 13 April 1999]There have been a total of 1,333 reports of suspected adverse drug reactions (ADRs) made via the UK spontaneous reporting scheme (the Yellow Card Scheme) associated with lamotrigine, of which 42 were fatal. Eighteen of the fatalities were associated with convulsions (the condition for which the drug was prescribed) and therefore it is difficult to establish what role, if any, the drug played in these cases. In general, doctors are asked to report suspected adverse drug reactions via the Yellow Card Scheme and therefore it is not possible to definitely attribute causality. Factors such as the patients' underlying illnesses and other medication may have contributed to the reactions.