Vigadrone

Last reviewed on RxList: 10/14/2020
Vigadrone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Vigadrone?

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.

What Are Side Effects of Vigadrone?

Common side effects of Vigadrone include:

Dosage for Vigadrone

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.

What Drugs, Substances, or Supplements Interact with Vigadrone?

Vigadrone may interact with phenytoin and clonazepam. Tell your doctor all medications and supplements you use.

Vigadrone During Pregnancy and Breastfeeding

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.

Additional Information

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

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Vigadrone Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Taking vigabatrin can cause permanent vision loss. Tell your doctor right away about any changes in your vision. If a child is taking vigabatrin: Tell the doctor right away if the child shows signs of vision changes, such as bumping into things or being easily startled or surprised.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • increased or worsening seizures;
  • any change in your vision, no matter how mild;
  • unusual or involuntary eye movements;
  • severe drowsiness, fussiness, or feeding problems (in a baby taking vigabatrin);
  • numbness, tingling, or burning pain in your hands or feet;
  • weight gain with or without swelling;
  • signs of an ear infection--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child; or
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Some babies treated with vigabatrin have had abnormal brain changes seen on magnetic resonance imaging (MRI). It is not known if these changes are caused by vigabatrin or if they are harmful. Tell any doctor who treats your baby that the child is taking vigabatrin.

Common side effects may include:

  • blurred vision or other eye problems;
  • drowsiness, dizziness, feeling tired;
  • problems with walking or coordination;
  • tremors or shaking;
  • aggressive behavior;
  • confusion, problems with thinking or memory;
  • weight gain;
  • joint pain;
  • cold symptoms such as stuffy nose, sneezing, sore throat; or
  • (in babies) fussiness, ear infection, cough, breathing problems.

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.

Read the entire detailed patient monograph for Vigadrone (Vigabatrin for Oral Solution)

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Vigadrone Professional Information

SIDE EFFECTS

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

  • Permanent Vision Loss [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Magnetic Resonance Imaging (MRI) Abnormalities in Infants [see WARNINGS AND PRECAUTIONS]
  • Neurotoxicity [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Withdrawal of Antiepileptic Drugs (AEDs) [see WARNINGS AND PRECAUTIONS]
  • Anemia [see WARNINGS AND PRECAUTIONS]
  • Somnolence and Fatigue [see WARNINGS AND PRECAUTIONS]
  • Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
  • Weight Gain [see WARNINGS AND PRECAUTIONS]
  • Edema [see WARNINGS AND PRECAUTIONS]

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. adjunctive clinical studies of refractory CPS in adults.

Table 5. Adverse Reactions in Pooled, Adjunctive Trials in Adults with Refractory Complex Partial Seizures

Vigabatrin dosage
(mg/day)
Body System
  Adverse Reaction
3,000
[N=134]
%
6,000
[N=43]
%
Placebo
[N=135]
%
Ear Disorders
  Tinnitus201
  Vertigo251
Eye Disorders
  Blurred vision13165
  Diplopia7163
  Asthenopia220
  Eye pain050
Gastrointestinal Disorders
  Diarrhea10167
  Nausea1028
  Vomiting796
  Constipation853
  Upper abdominal pain551
  Dyspepsia453
  Stomach discomfort421
  Abdominal pain321
  Toothache252
  Abdominal distension201
General Disorders
  Fatigue234016
  Gait disturbance6127
  Asthenia571
  Edema peripheral571
  Fever473
  Chest pain151
  Thirst200
  Malaise050
Infections
  Nasopharyngitis14910
  Upper respiratory tract infection796
  Influenza574
  Urinary tract infection450
  Bronchitis051
Injury
  Contusion352
  Joint sprain121
  Muscle strain121
  Wound secretion020
Metabolism and Nutrition Disorders
  Increased appetite151
  Weight gain6143
Musculoskeletal Disorders
  Arthralgia1053
  Back pain472
  Pain in extremity624
  Myalgia351
  Muscle twitching191
  Muscle spasms301
Nervous System Disorders
  Headache332631
  Somnolence222613
  Dizziness242617
  Nystagmus13199
  Tremor15168
  Memory impairment7163
  Abnormal coordination7162
  Disturbance in attention901
  Sensory disturbance472
  Hyporeflexia451
  Paraesthesia721
  Lethargy472
  Hyperreflexia423
  Hypoaesthesia451
  Sedation400
  Status epilepticus250
  Dysarthria221
  Postictal state201
  Sensory loss050
Psychiatric Disorders
  Irritability7237
  Depression6143
  Confusional state4141
  Anxiety403
  Depressed mood501
  Abnormal thinking370
  Abnormal behavior351
  Expressive language disorder171
  Nervousness252
  Abnormal dreams151
Reproductive System
  Dysmenorrhea953
  Erectile dysfunction050
Respiratory and Thoracic Disorders
  Pharyngolaryngeal pain7145
  Cough2147
  Pulmonary congestion051
  Sinus headache621
Skin and Subcutaneous Tissue Disorders
  Rash454

Pediatrics 3 to 16 years of age

Table 6 lists adverse reactions from controlled clinical studies of pediatric patients receiving vigabatrin or placebo as adjunctive 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, Adjunctive Trials in Pediatric Patients 3 to 16 Years of Age with Refractory Complex Partial Seizures

Body System
  Adverse Reaction
All VIGADRONE
[N=165]
%
Placebo
[N=104]
%
Eye Disorders
  Diplopia32
  Blurred vision20
Gastrointestinal Disorders
  Upper abdominal pain43
  Constipation21
General Disorders
  Fatigue107
Infections and Infestations
  Upper respiratory tract infection1511
  Influenza73
  Otitis media64
  Streptococcal pharyngitis43
  Viral gastroenteritis20
Investigations
  Weight gain152
Nervous System Disorders
  Somnolence65
  Tremor42
  Nystagmus43
  Status epilepticus21
Psychiatric Disorders
  Abnormal behavior76
  Aggression62
  Disorientation30

Safety of VIGADRONE for the treatment of refractory CPS in patients 2 years of age is expected to be similar to pediatric patients 3 to 16 years of age.

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 Spasms

Body System
  Adverse Reaction
Vigabatrin
Low Dose
[N=114]
%
Vigabatrin
High Dose
[N=108]
%
Eye Disorders (other than field or acuity changes)
  Strabismus55
  Conjunctivitis52
Gastrointestinal Disorders
  Vomiting1420
  Constipation1412
  Diarrhea1312
General Disorders
  Fever2919
Infections
  Upper respiratory tract infection5146
  Otitis media4430
  Viral infection2019
  Pneumonia1311
  Candidiasis83
  Ear infection714
  Gastroenteritis viral65
  Sinusitis59
Urinary tract infection56
  Influenza53
  Croup infectious51
Metabolism and Nutrition Disorders
  Decreased appetite97
Nervous System Disorders
  Sedation1917
  Somnolence1719
  Status epilepticus64
  Lethargy57
  Convulsion47
  Hypotonia46
Psychiatric Disorders
  Irritability1623
  Insomnia1012
Respiratory Disorders
  Nasal congestion134
  Cough38
Skin and Subcutaneous Tissue Disorders
  Rash811

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of vigabatrin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably 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), alopecia

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

© 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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