Vigabatrin (Sabril) can treat certain types of seizures: infantile spasms and complex partial seizures. It's available as a powder that's made into a solution and a tablet, both of which you take by mouth. The medication is typically taken twice daily. Vigabatrin (Sabril) is only available through the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) program because of the risk for permanent vision loss due to eye damage. Other side effects include sleepiness and dizziness. This medication is available as brand-name and lower-cost generic versions.
Vigabatrin (Sabril) is an antiepileptic (another name for anti-seizure medication). It's not exactly clear how it works to treat seizures. But it's thought to raise the levels of gamma-aminobutyric acid (GABA), a chemical in the brain that calms nerves. This helps control seizures.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Adults
Children age 3 to 16 years (for complex partial seizures)
Children age 1 month to 2 years (for infantile spasms)
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
More tips for the vigabatrin (Sabril) 500 mg powder packets for oral solution:
Based on available research, there isn't a clear time frame for when exactly vigabatrin (Sabril) will start to work. It might take a few days or weeks for the medication to start working for you. It'll probably depend on several factors, such as why you need vigabatrin (Sabril), your dose, how severe your seizures are, and what other seizure medications you're taking. One small study found that it took an average of 5 days for infantile spasms to go away completely in children who took vigabatrin (Sabril). For complex partial seizures in adults, there are mixed results as to how long it takes for the medication to work; it could range anywhere from about 2 weeks for vigabatrin (Sabril) to up to 3 months. Your provider will follow up with you regularly to discuss how well vigabatrin (Sabril) is working for you. They might adjust your dose as needed to reach the dose that will benefit you the most.
Since vigabatrin (Sabril) can put you at risk for permanent vision loss, the medication is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). The program for this medication is called the Vigabatrin REMS program. All providers who prescribe vigabatrin (Sabril), pharmacies that dispense vigabatrin (Sabril), and people who take vigabatrin (Sabril) must register with the REMS program. This is to make sure the medication is distributed and taken under the safest conditions possible for you. Your provider will discuss with you about the risk for permanent vision loss with vigabatrin (Sabril) and the need for regular eye check-ups during treatment.
Vigabatrin (Sabril) can damage the retina, which is the back part of your eye that senses light and sends signals to your brain so you can see. A damaged retina can cause changes in vision, such as blurry vision or vision loss. To lower your risk, it's recommended to use the lowest dose of vigabatrin (Sabril) that works to treat your condition. It's also recommended to get your eyes checked regularly. Discuss with your provider if you're concerned about this risk with vigabatrin (Sabril) treatment.
Yes, weight gain is a known side effect of vigabatrin (Sabril). Data from clinical studies found that 17% of adults and 47% of children gained at least 7% of the weight they were at before starting the medication. For this reason, it's important to keep track of your weight as well as have a healthy diet and exercise routine while taking vigabatrin (Sabril). Let your provider know if you or your child has gained an abnormal amount of weight after starting this medication.
Yes, vigabatrin (Sabril) is FDA approved for use in babies 1 month to 2 years of age with infantile spasms and in children 2 years of age or older with complex partial seizures. If your child is young and unable to swallow tablets, talk with your child's provider about the oral solution formulation. Keep in mind that vigabatrin (Sabril) can have side effects, like weight gain, vision loss, fatigue, and changes in behavior, that can affect your child's normal daily activities. It's important that your child gets regular check-ups while taking vigabatrin (Sabril) so they can be closely monitored for side effects. Talk to your child's provider if you're concerned your child is having side effects that don't go away or don't get better.
There's limited research done about the safety of vigabatrin (Sabril) during pregnancy. Small studies with pregnant women haven't been able to show that vigabatrin (Sabril) puts the mother or unborn baby at risk of serious harm. But animal studies found that babies were harmed when born to mothers exposed to the medication. In general, vigabatrin (Sabril) should only be used during pregnancy if it's clearly needed and the benefits are greater than the risks. If you're pregnant or thinking about becoming pregnant, talk with your provider about the benefits and risks of taking vigabatrin (Sabril). If you choose to take vigabatrin (Sabril) while pregnant, you're encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This registry helps monitor the safety of vigabatrin (Sabril) during your pregnancy.
Discuss with your provider if it's safe to breastfeed while you're taking vigabatrin (Sabril). Based on available research, vigabatrin (Sabril) isn't expected to cause side effects in breastfed babies. This is because the levels of the medication that are found in breast milk are much lower than the dose typically used for babies. But it's always a good idea to talk to your provider first to make sure breastfeeding while you're taking vigabatrin (Sabril) is the right option for you.
Vigabatrin (Sabril) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Vigabatrin (Sabril) can affect your vision, including causing blurry vision or making it hard to see things that aren't directly in front of you ("tunnel vision"). This medication can also cause vision loss, which can occur at any time after starting vigabatrin (Sabril) (within weeks of starting or after many months to years). This effect is permanent and might continue to get worse even after you stop taking the medication. Make sure to get your vision checked with a provider every 3 months while you're taking vigabatrin (Sabril) and at least one more time after you stop taking it. Tell your provider right away if you notice a change in your vision or if you're clumsier than usual, like tripping or bumping into things more easily.
Because of the risk of permanent vision loss with vigabatrin (Sabril), you, your provider, and your pharmacy are required to sign up with the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) program. This program makes sure that your provider checks your eye health regularly and that you understand this risk with taking the medication.
Young children who take vigabatrin (Sabril) can have abnormal MRIs (brain scans). These abnormalities might be due to nerve swelling in certain parts of the brain. In studies with young children with infantile spasms, the abnormalities went away in most cases after the medication was stopped. But there have been a few cases where they stayed even after stopping treatment. This unusual brain scan imaging isn't usually a problem for adults or children over 6 years of age. If this happens, your child's provider might want to try a different medication instead.
Vigabatrin (Sabril) raises your risk of having thoughts of suicide or harming yourself. This risk can appear as early as 1 week after you start taking vigabatrin (Sabril). If you or anyone around you notices that you have suicidal thoughts or unusual behavior (e.g., anxiety, panic attacks, difficulty sleeping, feeling angry or irritated, restlessness) while taking vigabatrin (Sabril), get medical help right away.
Antiepileptic (anti-seizure) medications like vigabatrin (Sabril) shouldn't be stopped suddenly because it can cause your seizures to come back. Don't stop taking vigabatrin (Sabril) without talking to your provider first. They'll instruct you on how to lower your dose slowly over time until you can completely stop taking it.
Some people taking vigabatrin (Sabril) developed anemia, a condition that happens when your red blood cell counts are low. Your provider might order tests to check your red blood cell count before and during treatment with vigabatrin (Sabril). Let your provider know if you notice possible symptoms of anemia, such as tiredness, weakness, pale skin, or getting short of breath more than usual.
Vigabatrin (Sabril) can cause extreme dizziness, tiredness, or sleepiness. These side effects can lower your ability to think, react, and focus. Your risk might be higher if you're taking other medications that can cause you to feel sleepy (e.g., benzodiazepines, muscle relaxants, sleep medications). Make sure you know how this medication affects you before driving a car or doing activities that require your concentration. Talk to your healthcare provider right away if you feel too sleepy from taking vigabatrin (Sabril).
Vigabatrin (Sabril) can cause nerve problems (called peripheral neuropathy) in adults. These nerve problems can include pain, numbness, or tingling in your feet. It might also lead to gradual problems with movement or reflexes. Let your provider know if you experience any abnormal sensations in your toes, feet, or ankles while you're taking this medication.
Vigabatrin (Sabril) can cause weight gain. This tends to be more common in children, but this effect can happen in adults as well. In clinical studies, the average weight gain in adults was about 8 pounds. Let your provider know if you or your child has gained an abnormal amount of weight after starting this medication.
The dose is the same for the tablet and powder for liquid.
Complex partial seizures
Infantile spasms: The dose is based on your child's body weight. The starting dose is 25 mg/kg by mouth twice per day. The maximum dose is 75 mg/kg twice per day.
Your provider will change the dose depending on how well the medication is working for you and if you're having side effects. Your dose might differ if you have kidney problems.