- 91 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* Drug interaction
In a case report, a 48-year-old man and 26-year-old woman were described, who developed de novo convulsive status epilepticus (CSE) following concomitant administration of fampridine and baclofen. Additionally, a 60-year-old woman was described, who developed de novo CSE following treatment with oxybutynin and biotin; concomitant administration of fampridine and baclofen or biotin also contributed to de novo CSE [not all routes and dosages stated].
Patient 1: A 60-year-old woman was diagnosed with relapsing remitting multiple sclerosis (MS) in 1989, and she had been treated with interferon β-1a. After many years, her clinical phenotype evolved into secondary progressive MS. In 2008, she was initiated on cyclophosphamide, followed by oral biotin 100mg three...
- Panicucci E, et al. De novo convulsive status epilepticus in patients with multiple sclerosis treated with dalfampridine. Multiple Sclerosis Journal 25: 618-621, No. 4, Apr 2019. Available from: URL: http://doi.org/10.1177/1352458518790379 - France