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Vigabatrin (vye GA ba trin) has been approved by the FDA as adjunctive therapy in refractory focal onset impaired awareness seizures in patients 2 years or older. In this instance, vigabatrin is not indicated as a first-line agent and should only be used on patients who have responded inadequately to several alternative treatments.

Vigabatrin has also been approved as monotherapy to treat infantile spasms in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.

How can you take vigabatrin? (Available formulations)

Vigabatrin is available as a tablet or a powder for oral solution taken with or without food.

Who should not take vigabatrin?

Other considerations may influence whether you should take vigabatrin. Tell your healthcare provider if you:

  • have or had an allergic reaction to vigabatrin, such as hives, itching, or trouble breathing.
  • have or had any vision problems.
  • have or had any kidney problems.
  • have or had low red blood cell counts (anemia).
  • have or have had depression, mood problems, or suicidal thoughts or behavior.
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed.

What is important to know about taking vigabatrin?

Do not stop taking vigabatrin suddenly unless directed to do so by your healthcare provider.

As with all antiseizure medications, vigabatrin should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using vigabatrin suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking vigabatrin with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Boxed warning

Vigabatrin is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by vigabatrin can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.

Permanent vision loss

Vigabatrin can cause permanent vision damage, including loss of peripheral vision and having blurry vision. Although vision loss is possible with any amount of vigabatrin, your risk may be greater with the more vigabatrin that you take daily and the longer you take it. Vision loss can happen at any time during treatment with vigabatrin. Vision loss is not likely to be noticed before it is severe. Tell your healthcare provider if you have or have ever had any vision problems. If you experience any of the following symptoms, call your healthcare provider immediately: think you are not seeing as well as before taking vigabatrin; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; blurry vision; double vision; eye movements you can’t control; eye pain; and headache.

Women or those who are/plan to become pregnant
Use in pregnancy

At this time, there is not enough evidence regarding developmental risks associated with the use of vigabatrin in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.

If you become pregnant while taking vigabatrin, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiseizure medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Use during breastfeeding

Vigabatrin is present in breast milk. It is unknown if there are effects on the breastfed infant, or if vigabatrin impacts milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for vigabatrin and the potential effect on the infant from vigabatrin or from your epilepsy.

What are the side effects of vigabatrin?

Common side effects

The most common side effects that were reported in studies of vigabatrin are:

Refractory focal onset impaired awareness seizures adults – blurred vision, drowsiness (somnolence), dizziness, abnormal coordination tremor, and fatigue.

  • children (3 – 16 years of age) – weight gain.

Infantile spasms

  • somnolence, bronchitis, ear infection, and acute otitis media.
Rare, but serious side effects
Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including vigabatrin may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.

MRI abnormalities in infants

In infants treated with vigabatrin, there have been reports of abnormal magnetic resonance imaging (MRI) in several regions of the brain, including lesions. Changes were generally resolved after discontinuing vigabatrin. No abnormal MRI results have been seen in adults taking vigabatrin.

Anemia

Anemia (low healthy red blood cells) has been reported in both adult and pediatric patients taking vigabatrin. If you experience symptoms of anemia talk with your healthcare provider.

Somnolence and fatigue

Vigabatrin can make you feel fatigued or drowsy (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how fenfluramine affects you.