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Vigadrone

Last reviewed on RxList: 6/17/2019
Vigadrone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/17/2019

Vigadrone (vigabatrin powder) is an anti-epileptic medicine (anticonvulsant) indicated as adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. It is also indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. Vigadrone is available as a generic. Common side effects of Vigadrone include:

The recommended dose of Vigadrone in adults is 3000 mg/day (1500 mg twice daily). Pediatric dosing of Vigadrone is based on the child's body weight. Vigadrone may interact with phenytoin and clonazepam. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Vigadrone; it is unknown how it would affect a fetus. Vigadrone passes into breast milk. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended while using Vigadrone.

Our Vigadrone (vigabatrin powder), for Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Epilepsy: Symptoms, Causes and Treatment See Slideshow
Vigadrone Professional Information

SIDE EFFECTS

The following serious and otherwise important adverse reactions are described elsewhere in labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In U.S. and primary non-U.S. clinical studies of 4,079 vigabatrin-treated patients, the most common (≥5%) adverse reactions associated with the use of vigabatrin in combination with other AEDs were headache, somnolence, fatigue, dizziness, convulsion, nasopharyngitis, weight gain, upper respiratory tract infection, visual field defect, depression, tremor, nystagmus, nausea, diarrhea, memory impairment, insomnia, irritability, abnormal coordination, blurred vision, diplopia, vomiting, influenza, pyrexia, and rash.

The adverse reactions most commonly associated with vigabatrin treatment discontinuation in ≥1% of patients were convulsion and depression.

In patients with infantile spasms, the adverse reactions most commonly associated with vigabatrin treatment discontinuation in ≥1% of patients were infections, status epilepticus, developmental coordination disorder, dystonia, hypotonia, hypertonia, weight gain, and insomnia.

Refractory Complex Partial Seizures

Adults

Table 5 lists the adverse reactions that occurred in ≥2% and more than one patient per vigabatrin treated group and that occurred more frequently than in placebo patients from 2 U.S. add-on clinical studies of refractory CPS in adults.

Table 5: Adverse Reactions in Pooled, Add-On Trials in Adults with Refractory Complex Partial Seizures

Body System Adverse Reaction Vigabatrin dosage
(mg/day)
3,000
[N=134] %
6,000
[N=43] %
Placebo
[N=135] %
Ear Disorders
Tinnitus 2 0 1
Vertigo 2 5 1
Eye Disorders
Blurred vision 13 16 5
Diplopia 7 16 3
Asthenopia 2 2 0
Eye pain 0 5 0
Gastrointestinal Disorders
Diarrhea 10 16 7
Nausea 10 2 8
Vomiting 7 9 6
Constipation 8 5 3
Upper abdominal pain 5 5 1
Dyspepsia 4 5 3
Stomach discomfort 4 2 1
Abdominal pain 3 2 1
Toothache 2 5 2
Abdominal distension 2 0 1
General Disorders
Fatigue 23 40 16
Gait disturbance 6 12 7
Asthenia 5 7 1
Edema peripheral 5 7 1
Fever 4 7 3
Chest pain 1 5 1
Thirst 2 0 0
Malaise 0 5 0
Infections
Nasopharyngitis 14 9 10
Upper respiratory tract infection 7 9 6
Influenza 5 7 4
Urinary tract infection 4 5 0
Bronchitis 0 5 1
Injury
Contusion 3 5 2
Joint sprain 1 2 1
Muscle strain 1 2 1
Wound secretion 0 2 0
Metabolism and Nutrition Disorders
Increased appetite 1 5 1
Weight gain 6 14 3
Musculoskeletal Disorders
Arthralgia 10 5 3
Back pain 4 7 2
Pain in extremity 6 2 4
Myalgia 3 5 1
Muscle twitching 1 9 1
Muscle spasms 3 0 1
Nervous System Disorders
Headache 33 26 31
Somnolence 22 26 13
Dizziness 24 26 17
Nystagmus 13 19 9
Tremor 15 16 8
Memory impairment 7 16 3
Abnormal coordination 7 16 2
Disturbance in attention 9 0 1
Sensory disturbance 4 7 2
Hyporeflexia 4 5 1
Paraesthesia 7 2 1
Lethargy 4 7 2
Hyperreflexia 4 2 3
Hypoaesthesia 4 5 1
Sedation 4 0 0
Status epilepticus 2 5 0
Dysarthria 2 2 1
Postictal state 2 0 1
Sensory loss 0 5 0
Psychiatric Disorders
Irritability 7 23 7
Depression 6 14 3
Confusional state 4 14 1
Anxiety 4 0 3
Depressed mood 5 0 1
Abnormal thinking 3 7 0
Abnormal behavior 3 5 1
Expressive language disorder 1 7 1
Nervousness 2 5 2
Abnormal dreams 1 5 1
Reproductive System
Dysmenorrhea 9 5 3
Erectile dysfunction 0 5 0
Respiratory and Thoracic Disorders
Pharyngolaryngeal pain 7 14 5
Cough 2 14 7
Pulmonary congestion 0 5 1
Sinus headache 6 2 1
Skin and Subcutaneous Tissue Disorders
Rash 4 5 4

Pediatrics 10 To 16 Years Of Age

Table 6 lists adverse reactions from controlled clinical studies of pediatric patients receiving vigabatrin or placebo as add-on therapy for refractory complex partial seizures. Adverse reactions that are listed occurred in at least 2% of vigabatrin-treated patients and more frequently than placebo. The median vigabatrin dose was 49.4 mg/kg (range of 8.0 to 105.9 mg/kg).

Table 6: Adverse Reactions in Pooled, Add-On Trials in Pediatric Patients 10 to 16 Years of Age with Refractory Complex Partial Seizures

Body System Adverse Reartion All Vigabatrin
[N=109] %
Plarebo
[N=46] %
Eye Disorders
Diplopia 5 0
Blurred vision 3 0
Gastrointestinal Disorders
Diarrhea 6 2
Upper abdominal pain 3 0
Constipation 3 2
General Disorders
Fatigue 9 4
Infections and Infestations
Upper respiratory trart infertion 10 4
Influenza 6 2
Otitis media 6 2
Investigations
Weight gain 17 2
Nervous System Disorders
Somnolenre 6 2
Tremor 6 0
Nystagmus 5 2
Psyrhomotor hyperartivity 4 2
Psychiatric Disorders
Abnormal behavior 6 2
Aggression 5 0
Disorientation 4 0
Reproduction and Breast Disorders
Dysmenorrhea 3 0
Skin and Subcutaneous Tissue Disorders
Arne 3 0

Infantile Spasms

In a randomized, placebo-controlled IS study with a 5 day double-blind treatment phase (n=40), the adverse reactions that occurred in >5% of patients receiving vigabatrin and that occurred more frequently than in placebo patients were somnolence (vigabatrin 45%, placebo 30%), bronchitis (vigabatrin 30%, placebo 15%), ear infection (vigabatrin 10%, placebo 5%), and acute otitis media (vigabatrin 10%, placebo 0%).

In a dose response study of low-dose (18 to 36 mg/kg/day) versus high-dose (100 to 148 mg/kg/day) vigabatrin, no clear correlation between dose and incidence of adverse reactions was observed. The adverse reactions (≥5% in either dose group) are summarized in Table 7.

Table 7: Adverse Reactions in a Placebo-Controlled Trial in Patients with Infantile Spas ms

Body System Adverse Reaction Vigabatrin Low Dose
[N=114] %
Vigabatrin High Dose
[N=108] %
Eye Disorders (other than field or acuity changes)
Strabismus 5 5
Conjunctivitis 5 2
Gastrointestinal Disorders
Vomiting 14 20
Constipation 14 12
Diarrhea 13 12
General Disorders
Fever 29 19
Infections
Upper respiratory tract infection 51 46
Otitis media 44 30
Viral infection 20 19
Pneumonia 13 11
Candidiasis 8 3
Ear infection 7 14
Gastroenteritis viral 6 5
Sinusitis 5 9
Urinary tract infection 5 6
Influenza 5 3
Croup infectious 5 1
Metabolism and Nutrition Disorders
Decreased appetite 9 7
Nervous System Disorders
Sedation 19 17
Somnolence 17 19
Status epilepticus 6 4
Lethargy 5 7
Convulsion 4 7
Hypotonia 4 6
Psychiatric Disorders
Irritability 16 23
Insomnia 10 12
Respiratory Disorders
Nasal congestion 13 4
Cough 3 8
Skin and Subcutaneous Tissue Disorders
Rash 8 11

Post Marketing Experience

The following adverse reactions have been reported during post approval use of vigabatrin worldwide. All adverse reactions that are not listed above as adverse reactions reported in clinical trials, that are not relatively common in the population and are not too vague to be useful are listed in this section. These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions are categorized by system organ class.

Birth Defects: Congenital cardiac defects, congenital external ear anomaly, congenital hemangioma, congenital hydronephrosis, congenital male genital malformation, congenital oral malformation, congenital vesicoureteric reflux, dentofacial anomaly, dysmorphism, fetal anticonvulsant syndrome, hamartomas, hip dysplasia, limb malformation, limb reduction defect, low set ears, renal aplasia, retinitis pigmentosa, supernumerary nipple, talipes

Ear Disorders: Deafness

Endocrine Disorders: Delayed puberty

Gastrointestinal Disorders: Gastrointestinal hemorrhage, esophagitis

General Disorders: Developmental delay, facial edema, malignant hyperthermia, multi-organ failure

Hepatobiliary Disorders: Cholestasis

Nervous System Disorders: Dystonia, encephalopathy, hypertonia, hypotonia, muscle spasticity, myoclonus, optic neuritis, dyskinesia

Psychiatric Disorders: Acute psychosis, apathy, delirium, hypomania, neonatal agitation, psychotic disorder

Respiratory Disorders: Laryngeal edema, pulmonary embolism, respiratory failure, stridor

Skin and Subcutaneous Tissue Disorders: Angioedema, maculo-papular rash, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)

Read the entire FDA prescribing information for Vigadrone (Vigabatrin for Oral Solution)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Related Resources for Vigadrone

© Vigadrone Patient Information is supplied by Cerner Multum, Inc. and Vigadrone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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