Document Detail

Adverse event monitoring in lamotrigine patients: a pharmacoepidemiologic study in the United Kingdom.
MedLine Citation:
PMID:  11240596     Owner:  NLM     Status:  MEDLINE    
PURPOSE: This postmarketing surveillance study of lamotrigine (LTG) was performed to provide complementary data to large-scale Prescription-Event Monitoring study with a retrospective case records survey in five tertiary referral epilepsy centres in the United Kingdom.
METHODS: Adverse events were recorded and compared with those of two other new antiepileptic drugs (AEDs), gabapentin (GBP) and vigabatrin (VGB). All deaths were followed up and standardised mortality ratios (SMRs) were calculated. Serious adverse events were assessed individually.
RESULTS: A total of 2,701 patients was identified as being exposed to LTG and/or the comparators. It was necessary to exclude 1,326 patients because LTG and/or comparators had been commenced outside the study centres. The adverse events with LTG reported by this study were similar to those reported in the literature. Skin rash was the major adverse event. Life-threatening hepatic failure, acute exacerbation of ulcerative colitis, disseminated intravascular coagulation, and renal failure were reported. No death could be directly attributed to the use of LTG. The SMR was slightly higher than that reported in the literature; this probably reflects severity of epilepsy in the study population.
CONCLUSIONS: The safety profile of LTG was similar to that in the large-scale Prescription-Event Monitoring study and generally acceptable. Life-threatening adverse reactions were rare.
I C Wong; G E Mawer; J W Sander
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Epilepsia     Volume:  42     ISSN:  0013-9580     ISO Abbreviation:  Epilepsia     Publication Date:  2001 Feb 
Date Detail:
Created Date:  2001-03-12     Completed Date:  2001-03-29     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  2983306R     Medline TA:  Epilepsia     Country:  United States    
Other Details:
Languages:  eng     Pagination:  237-44     Citation Subset:  IM    
Pharmacy Practice, School of Pharmacy, University of Bradford, Bradford, BD7 1DP, UK.
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MeSH Terms
Acetates / adverse effects*,  therapeutic use
Adverse Drug Reaction Reporting Systems / statistics & numerical data*
Anticonvulsants / adverse effects*,  therapeutic use
Cyclohexanecarboxylic Acids*
Death, Sudden / epidemiology,  etiology
Drug Eruptions / epidemiology,  etiology
Epilepsy / drug therapy*
Great Britain / epidemiology
Middle Aged
Neurotoxicity Syndromes / epidemiology,  etiology,  mortality
Pharmacoepidemiology / statistics & numerical data
Product Surveillance, Postmarketing
Triazines / adverse effects*,  therapeutic use
Vigabatrin / adverse effects,  therapeutic use
gamma-Aminobutyric Acid*
Reg. No./Substance:
0/Acetates; 0/Amines; 0/Anticonvulsants; 0/Cyclohexanecarboxylic Acids; 0/Triazines; 56-12-2/gamma-Aminobutyric Acid; 60643-86-9/Vigabatrin; 6CW7F3G59X/gabapentin; U3H27498KS/lamotrigine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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