§ 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 of the 35 inquiries referred to (a) the incident or event which gave rise to the inquiry, (b) the name and address of the person who generated the inquiry, (c) details of the nature of the inquiry and (d) the steps which (i) his Department and (ii) the Medicines Control Agency have taken in response to the inquiry. [80231]
§ Mr. Denham[holding answer 13 April 1999]: Details of the 35 inquiries received by the Medicines Control Agency relating to lamotrigine from health professionals and members of the public since the marketing authorisation was granted are shown in the table. In many cases, the incident or event which gave rise to the inquiry is not known. Under the Data Protection Act the names and addresses of the inquirers have been withheld and cannot be provided without the written permission of the individuals concerned. In most cases, the nature of the inquiries was to seek information on adverse drug reactions to lamotrigine, which is routinely provided on request to health professionals and members of the public by the Medicines Control Agency.
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Inquiries relating to lamotrigine received by the Medicines Control Agency up to April 1999 Reason for inquiry Inquirer Nature of inquiry (information requested) Response Not known Doctor Information on reduced white blood cell count with carbamazepine and lamotrigine Drug Analysis Prints1 (DAPs) provided A patient with hair loss Doctor Information on hair loss with lamotrigine DAP and details of reports of hair loss provided An ADR reporting study Doctor Information on ADR reports in the Grampian Region for citalopram, gabapentin, lamotrigine, moclobemide, nefazodone, tramadol, venlafazine, topiramate and fentanyl patches Details of reports provided 24W
Inquiries relating to lamotrigine received by the Medicines Control Agency up to April 1999 Reason for inquiry Inquirer Nature of inquiry (information requested) Response A Pathologist had carried out an autopsy on patient who had taken lamotrigine Doctor Information on deaths reported in association with lamotrigine DAP and details of fatal reports provided Not Known Doctor Information on ADRs with lamotrigine (Particularly aggression) DAP provided Not Known Pharmacist Information ADRs to lamotrigine (Particularly liver reactions) DAP provided The doctor was reporting a patient with dizziness and vomiting on lamotrigine Doctor Information on ADRs to lamotrigine DAP provided The inquirer was editing a textbook Doctor Information related to psychiatric ADRs with gabapentin, lamotrigine, vigabatrin, topiramate, clobazam and felbamate DAP provided Not Known Doctor Information on ADRs with lamotrigine DAP provided Not Known Doctor Information on ADRs with lamotrigine DAP Provided The inquirer was carrying our research on ADRs with antiepileptics Doctor Information on ADRs with lamotrigine, vigabatrin, gabapentin DAPs provided The inquirer needed information for a court report Doctor Information on cases of aggression, agitation, confusion, personality change and restlessness Information on reports provided Not Known Pharmacist Information on ADRs with lamotrigine DAP provided Not Known Doctor Information on yellow macular pigment with carbamazepine and lamotrigine DAPs provided Not known Doctor Information on uveitis with lamotrigine and sodium valproate DAPs provided Not known Pharmacist Information on lamotrigine and carbamazepine and ecchymoses and capillary fragility DAPs provided Not Known Doctor Information on ADRs with lamotrigine DAP provided 25W
Inquiries relating to lamotrigine received by the Medicines Control Agency up to April 1999 Reason for inquiry Inquirer Nature of inquiry (information requested) Response Not known Pharmacist Information on lamotrigine and hormone replacement therapy when used together DAPs provided Concern over press coverage of lamotrigine and skin reactions Doctor Further information requested Information provided over telephone Not known Pharmacist Information on pruritus and rashes with lamotrigine DAP provided Not known Pharmacist Information on gastrointestinal blockage vigabatrin, carbamazepine and lamotrigine DAPs provided Two patients on sodium valproate developed thrombocytopenia when lamotrigine was added Pharmacist Information on any other reports involving sodium valproate and lamotrigine Details of relevant reports provided Not known Pharmacist Information on visual hallucinations with lamotrigine DAP and details of reports provided Not known Doctor Information on hypogammaglobinaemia with lamotrigine and vigabatrin DAPs provided Not known Pharmacist Information on urinary incontinence with lamotrigine DAPs provided Not known Pharmacist Information on ADRs with lamotrigine DAP provided Not known Doctor Information on ADRs with gabapentin, vigabatrin and lamotrigine DAPs provided Not known Pharmacist Information on raised liver enzymes with lamotrigine DAP provided Not known Pharmacist Information on ADRs with lamotrigine and haloperidol DAPs provided Not known Pharmacist Information on ADRs indomethacin and diclofenac DAPs provided Not known Doctor Information on psychiatric ADRs with lamotrigine DAP provided Issue of skin reactions Regulatory authority Information on serious skin reactions with amotrigine Details of reports provided
Inquiries relating to lamotrigine received by the Medicines Control Agency up to April 1999 Reason for inquiry Inquirer Nature of inquiry (information requested) Response Not known Member of the public Information on ADRs with lamotrigine DAP provided Confusion over the brand names Lamicta and Lamasil GP Practice Manager Inquiry as to whether there was a list of drugs with similar names which could cause confusion No such list was known Parliamentary question Martin Redmond MP What research his Department has carried out into a comparison of lamotrigine and valproate monotherapy in patients with primary generalised seizures; with what findings Hansard reference 263 c922-3W 1A Drug Analysis Print (DAP) gives a complete list of all suspected adverse reactions reported through the Yellow Card Scheme to the Committee on Safety of Medicines (CSM)/Medicines Control Agency (MCA) in association with the named drug substance.