| Adverse event monitoring in lamotrigine patients: a pharmacoepidemiologic study in the United Kingdom. | |
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MedLine Citation:
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PMID: 11240596 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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I C Wong; G E Mawer; J W Sander |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Epilepsia Volume: 42 ISSN: 0013-9580 ISO Abbreviation: Epilepsia Publication Date: 2001 Feb |
Date Detail:
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Created Date: 2001-03-12 Completed Date: 2001-03-29 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 2983306R Medline TA: Epilepsia Country: United States |
Other Details:
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Languages: eng Pagination: 237-44 Citation Subset: IM |
Affiliation:
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Pharmacy Practice, School of Pharmacy, University of Bradford, Bradford, BD7 1DP, UK. i.c.k.wong@bradford.ac.uk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acetic Acids
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adverse effects*,
therapeutic use Adolescent Adult Adverse Drug Reaction Reporting Systems / statistics & numerical data* Aged Amines* Anticonvulsants / adverse effects*, therapeutic use Child Cyclohexanecarboxylic Acids* Death, Sudden / epidemiology, etiology Drug Eruptions / epidemiology, etiology Epilepsy / drug therapy* Female Great Britain / epidemiology Humans Incidence Male 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* |
| Chemical | |
Reg. No./Substance:
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0/Acetic Acids; 0/Amines; 0/Anticonvulsants; 0/Cyclohexanecarboxylic Acids; 0/Triazines; 56-12-2/gamma-Aminobutyric Acid; 60142-96-3/gabapentin; 60643-86-9/Vigabatrin; 84057-84-1/lamotrigine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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