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Published on: July 29, 2015
The potential for vigabatrin-induced intramyelinic edema in humans
J A Cohen1, R S Fisher, M G Brigell
1Mellen Center for Multiple Sclerosis Treatment and Research, Department of Neurology, Cleveland Clinic Foundation, Ohio 44195, USA.
Vigabatrin (VGB) is an antiepilepsy drug effective for seizures. Despite animal studies showing potential for intramyelinic edema (IME), extensive human data reveals no confirmed cases of VGB-induced IME.
Area of Science:
- Neurology
- Pharmacology
- Toxicology
Background:
- Vigabatrin (VGB) is an antiepilepsy drug (AED) used globally for partial and generalized seizures, and infantile spasms.
- While effective and safe in humans, animal studies indicated a risk of intramyelinic edema (IME) with prolonged VGB administration.
Purpose of the Study:
- To evaluate the potential for VGB-induced intramyelinic edema (IME) in humans.
- To correlate animal findings with human clinical data and post-mortem/surgical brain samples.
Main Methods:
- Review of animal and human data regarding VGB-induced IME.
- Long-term surveillance (>15 years) of patients receiving VGB in clinical trials and prescriptions.
- Histopathological examination of brain samples from VGB-treated patients.
Main Results:
- Animal models reliably show VGB-induced IME, correlating with evoked potentials (EPs) and MRI changes.
- Extensive studies in epilepsy patients using EP and MRI showed no clear IME-related changes.
- Across an estimated 350,000 patient-years of VGB exposure, no definite cases of VGB-induced IME were identified.
Conclusions:
- Comprehensive data review failed to identify any definitive cases of intramyelinic edema (IME) in humans treated with Vigabatrin (VGB).
- The safety profile of VGB in humans appears robust concerning IME.
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