§ Mr. LockTo ask the Secretary of State for Health, pursuant to his answer of 30 March 1999,Official Report, columns 656–57, on Lamotrigine, if he will list for each further evaluation undertaken or commissioned by the Medicines Control Agency in respect of Lamotrigine, (a) the name of the individual body who was instructed to carry out the further research, (b) the terms of reference of the research, (c) the cost of the research and (d) when and where the results of the research were or are planned to be published. [80229]
§ Mr. Denham[holding answer 13 April 1999]The safety of all marketed medicines is continually monitored by the Medicines Control Agency through the Yellow Card Scheme which collects reports of suspected adverse reactions. Lamotrigine is closely monitored under the Black Triangle Scheme, by which new drugs are 269W intensively monitored for the first few years of marketing until their safety profile is established. Marketing Authorisation holders are responsible for providing the Medicines Control Agency with all information relating to the safety of their drugs. In addition, owing to the issue of serious skin reactions associated with Lamotrigine, the safety of Lamotrigine is reviewed regularly at a European level at the Pharmacovigilance Working Party of the Committee on Proprietary Medicinal Products. Information about the safety of Lamotrigine in general, and skin reactions in particular, were published in the Medicines Control Agency/Committee on Safety of Medicines drug safety bulletin "Current Problems in Pharmacovigilance" in February 1993, October 1996 and May 1997. Copies have been placed in the Library.
The Medicines Control Agency has not commissioned any research in respect of Lamotrigine.