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Who are the rare disease drugs vigabatrin tablets suitable for: Orphan drugs can be used for adults and children (10 years old and above) with refractory complex partial epilepsy (CPS, also known as focal epilepsy). People who are severely allergic to Vigabatrin or any excipients in the drug are prohibited from taking it.

Patients should pay attention to the following when using the rare disease drug vigabatrin tablets:

The incidence of visual field defects is high (approximately one third) in patients taking vigabatrin tablets. This often occurs after several months to several years of using Vigabatrin. Visual field defects can be severe, which can have real consequences for the patient. Most patients with visual field loss have no obvious symptoms.

Pregnancy and Breastfeeding There are a limited number of surveyable data on the use of Vigabatrin during pregnancy (192 cases). 14.5% of those taking Vigabatrin during pregnancy had congenital anomalies. Among them, 64.3% were major deformities. Spontaneous miscarriage occurred in 10.9% of women taking Vigabatrin during pregnancy. Due to limited clinical reporting data on epilepsy and concomitant use of antiepileptic drugs, we cannot definitively conclude whether vigabatrin increases the risk of malformations during pregnancy. There are no data indicating that children with visual field defects may develop in utero while taking Vigabatrin. Reproductive toxicity has emerged in experimental studies in animals. These relevant data are not yet known for humans.

Effects on ability to drive and use machinery Generally, patients with uncontrolled epilepsy are not allowed to drive or operate potentially dangerous machinery. Given reports of drowsiness with clinical use of Vigabatrin, patients should be warned before initiating treatment.

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