Ross is a writer for Verywell with years of experience practicing pharmacy in various settings. She is also a board-certified clinical pharmacist and the founder of Off Script Consults.
Femi Aremu, PharmD, is a professional pharmacist with experience in clinical and community pharmacy. He currently practices in Chicago, Illinois.
The Food and Drug Administration (FDA) gave this medication a black box warning of possible vision loss. Therefore, Sabril is available only through a Risk Evaluation Mitigation Strategy (REMS) program.
Sabril (vigabatrin ) is an anti-seizure medication, also known as an anticonvulsant or antiepileptic drug (AED). It's thought to treat seizures by preventing the y-aminobutyric acid transaminase (GABA-T) protein from breaking down GABA. GABA is a naturally occurring chemical in the central nervous system (brain and spinal cord). Inhibiting GABA-T results in higher amounts of GABA.
Sabril is available as a prescription tablet. It also comes in a powder that turns into a liquid solution when mixed with water. The Food and Drug Administration (FDA) gave this medication a black box warning of possible vision loss. Therefore, Sabril is available only through a Risk Evaluation Mitigation Strategy (REMS) program.
Brand Name(s): Sabril
Therapeutic Classification: Anticonvulsant (antiepileptic drug)
Controlled Substance: N/A
Administration Route: Oral (by mouth)
Dosage Form(s): Tablets and liquid (when the powder is mixed with water)
Sabril is used to treat seizures—specifically infantile spasms (IS) and refractory complex partial seizures (CPS).
The FDA approved Sabril to be used by itself for IS in children between 1 month and age 2. Sabril should only be used for IS if the benefits outweigh the risk of vision loss.
Sabril is also an add-on to another anti-seizure treatment for refractory CPS in people 2 years or older. CPS is also known as focal seizure with impaired awareness. People with this medical condition have seizures that start on one side of the brain. These seizures can also cause you to lose awareness or consciousness.
CPS will not get any better for some people after a trial of two to three antiepileptic drugs (AEDs). Therefore, these seizures are called refractory.
In 2015, the Centers for Disease Control and Prevention (CDC) estimated that 3 million adults and nearly 500,000 children had epilepsy in the United States (U.S.). People with epilepsy have a history of at least two seizures.
In general, Sabril is taken by mouth twice daily with or without food.
Compared to Sabril tablets, the liquid dosage form will require more preparation steps before you can take the medication. Specific directions will vary per person. Therefore, take Sabril according to your healthcare provider's recommendations. The following are some general steps to prepare and take the Sabril liquid solution.
When you receive Sabril from the pharmacy, store it at room temperature, which is between 68 degrees to 77 degrees Fahrenheit (F).
To be safe, you may also place Sabril in a locked cabinet or closet to keep your medication out of the reach of children and pets.
If you plan to travel with Sabril, get familiar with your final destination's regulations. Checking with the U.S. embassy or consulate might be a helpful resource. In general, however, be sure to make a copy of your Sabril prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, be sure to ask your pharmacist or healthcare provider.
You can also ask your pharmacist or healthcare provider about the best ways to dispose of your medications. The FDA's website is a potentially helpful resource to know where and how to discard all unused and expired drugs. You can also find disposal boxes in your area.
You should notice an improvement within three months for refractory complex partial seizures. As for infantile spasms, your child's symptoms should improve within two to four weeks. If there is no improvement by these timelines, your healthcare provider may discontinue Sabril treatment.
Sabril doesn't currently have any off-label uses.
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common side effects with Sabril for refractory complex partial seizures (CPS) in adults may include:
Children between ages 3 to 16 tend to experience weight gain with Sabril for refractory CPS.
On the other hand, children between 1 month and 2 years tend to have the following common side effects with Sabril for infantile spasms.
Serious side effects and their symptoms include:
Get medical help right away if you develop any of these side effects. Call 911 if your symptoms feel life-threatening.
Possible long-term side effects with Sabril may include vision loss and nerve problems.
Sabril may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
The following modifications (changes) should be kept in mind when using Sabril:
Severe allergic reaction: If you have a severe allergic reaction to Sabril, your healthcare provider wouldn't recommend this medication.
Pregnancy: In animal studies, Sabril was found to have adverse (negative) effects on the fetus. If taking Sabril during your pregnancy, consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by visiting the registry's website or calling 1-888-233-2334. Based on currently available information for humans, there are no reports that linked Sabril to negative effects on the unborn fetus.
Discuss with your healthcare provider if you are or plan to become pregnant. They will help you weigh the benefits and risks of taking Sabril during pregnancy.
Breastfeeding: While Sabril is present in human breast milk, the amount is low for daily doses of up to 2000 milligrams (mg). In fact, the Sabril levels in breast milk are less than the typical dosage range given to a 1-month-old child with infantile spasms (IS). As a result, negative effects on the nursing baby are unlikely.
Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider will help you weigh the benefits and harms of taking Sabril while nursing. They can also discuss the different ways available to feed your baby.
Adults over 65: Clinical studies haven't included a large enough number of people in this age group to see whether they respond differently from younger adults. Since some older adults may have kidney impairment, use Sabril with caution in this population.
Children: Sabril—as an add-on to another seizure treatment option—can be used for refractory complex partial seizures (CPS) in children between 2 and 16 years old. Sabril is also used for IS in children between 1 month and 2 years if the benefits outweigh the risk of vision loss.
Kidney problems: Individuals with kidney problems may not be able to clear Sabril from their bodies as quickly. This means the medicine stays in the body longer and can have increased side effects. For this reason, your healthcare provider will adjust your Sabril dosage based on your kidney function.
Liver problems: Sabril may lower your liver function test levels. Therefore, your healthcare provider isn't likely to use these tests if they suspect worsening liver function from any cause.
If you accidentally forgot your Sabril dose, take it as soon as you remember. If it's already close to your next scheduled dose, however, then skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.
These suggestions might vary per person. Therefore, make sure to ask for specific recommendations from your healthcare provider.
Try to find ways to help yourself remember to routinely take your medication that works for you. If you miss too many doses, Sabril might be less effective at treating your seizures.
There have been reports of overdoses with Sabril at doses between 3 to 90 grams (g)—with most overdoses happening between 7 1/2 to 30 grams of Sabril in combination with other antiepileptic drugs(AEDs).
The symptoms of a suspected overdose with Sabril may include:
If you think that you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.
If you think you or someone else may have overdosed on Sabril, call a healthcare provider or the Poison Control Center (800-222-1222).
If someone collapses or isn't breathing after taking Sabril, call 911 immediately.
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause permanent vision loss. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. It is very important that your ophthalmologist (eye doctor) check your child's or your eyes within 4 weeks after starting treatment, every 3 months during treatment, and about 3 to 6 months after stopping treatment with this medicine.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine (eg, magnetic resonance imaging or MRI).
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.
This medicine may cause some people to become drowsy, sleepy, tired, or weak than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.
Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
This medicine may increase your weight and cause swelling in your hands, ankles, or feet. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want to gradually reduce the amount you are using before stopping it completely. Stopping this medicine suddenly may cause seizures.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Before taking Sabril, talk with your healthcare provider if any of the following applies to you:
Use caution when taking Sabril with the following medications:
For more detailed information about medication interactions with Sabril, talk with your pharmacist or healthcare provider.
And be sure to talk with your healthcare provider about any other medicines that you take or plan to take, including over-the-counter, nonprescription products, vitamins, herbs, or plant-based medicines.
Several antiepileptic drugs (AEDs) are available to treat seizures. In general, AEDs are divided into two groups: broad-spectrum and narrow-spectrum AEDs. Broad-spectrum AEDs can typically be used for various seizure types. Narrow-spectrum AEDs are generally only used for specific seizure types.
Sabril is considered a narrow-spectrum AED, and other narrow-spectrum AEDs include:
Compared to all of these narrow-spectrum AEDs, Sabril is the only AED recommended as an initial go-to medication to treat infantile spasms (IS). For refractory complex partial seizures (CPS), however, Sabril isn't the first-choice option due to its risk of vision loss. While Sabril is available as the generic vigabatrin, it's a specialty medication. As a result, it might be more expensive than the other narrow-spectrum AEDs.
Sabril isn't typically available at your local retail pharmacy. In fact, Sabril is a specialty medication. Therefore, your healthcare provider may need to send a Sabril prescription to a specialty pharmacy.
Sabril also has a Risk Evaluation Mitigation Strategy (REMS) program. As a result, your healthcare provider and pharmacy will also need to be REMS-certified.
Although Sabril is available as the generic vigabatrin, it's a specialty medication. As a result, Sabril might be costly.
If cost is a concern, Sabril's manufacturer may offer a reimbursement support program. For additional information, call Lundbeck at 1-888-457-4273. Other potentially helpful resources may also include RxAssist, NeedyMeds, Rx Outreach, or Simplefill.
Sabril may lower your number of seizures, but it isn't a cure for your epilepsy condition. In general, Sabril can't completely get rid of your seizures.
Sabril may lower the amount of phenytoin in your body. Therefore, your healthcare provider may need to adjust your medication dose.
As for other AEDs, there is typically little concern about AED interactions with Sabril.
Sabril is unlikely to lower the effectiveness of your hormonal birth control.
Bone loss isn't listed as a common or serious side effect of Sabril. In fact, Sabril's prescribing information didn't include any of the following bone-related side effects: osteoporosis, osteopenia, or low bone mineral density (BMD) from a DEXA scan.
Sabril, however, is typically combined with another antiepileptic drug (AED) for refractory complex partial seizures (CPS). Although Sabril might not be linked to bone problems, the other AED might.
If you're taking Sabril, chances are seizures have been negatively affecting your quality of life. You may have tried different approaches or treatments. While living with epilepsy does have its challenges, there are ways to help improve your quality of life. Refer below for some general tips to support your health:
Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.
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