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Post-Marketing Surveillance With Gabapentin Reveals Only Previously Documented Neurological Side Effects
A DGReview of :"A postmarketing surveillance study of gabapentin as add-on therapy for 3,100 patients in England"
Epilepsia
10/25/2002
By Alison Palkhivala
A post-marketing surveillance of gabapentin found that although the drug caused the expected neurological side effects such as drowsiness, dizziness and lassitude, there were no unrecognized adverse events.
L. V. Wilton and S. Shakir from the Drug Safety Research Unit, Southampton, England, conducted this on the use of gabapentin as an add-on therapy for the treatment of epilepsy. They identified patients taking gabapentin in this manner from records about dispensing of prescriptions kept by the National Health Service. Approximately six months after the initial prescription, the investigators sent the patients' physicians questionnaires about the patient demographics and use of gabapentin.
Among the 3,100 patients who comprised the cohort of this observational study, 136 were children. The median duration of gabapentin use among these patients was 8.1 months. The most frequently reported adverse events during the first month of treatment were drowsiness/sedation, dizziness and malaise/lassitude. These adverse events were also the ones most commonly cited as reasons for discontinuing the drug.
Eleven women in the cohort used gabapentin during the first trimester of their pregnancy, and none gave birth to babies with congenital abnormalities. Crude mortality rate among the patients taking gabapentin was five times that of the general population but no higher than those reported by other studies.
Epilepsia 2002 Sep;43(9):983-92.
"A postmarketing surveillance study of gabapentin as add-on therapy for 3,100 patients in England"
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