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My doctor and i talked about the risks.

Permanent Vision Loss and Sabril

The most important side effect information patients and/or parents should know is that Sabril can permanently damage the vision of anyone who takes it. People taking Sabril are at risk for vision loss with any amount of Sabril. And the risk of vision loss may be higher the more Sabril is taken daily and the longer it's taken. This side effect has occurred in 30% or more of patients taking Sabril. If vision loss occurs, it will not get better.1,2

Click any of the links below to learn more about this permanent vision loss:

Types of Vision Loss

Vision is divided into 2 categories: peripheral and central. Peripheral vision is what you can see from the corners and the tops and bottoms of your eyes when you are looking straight ahead. Central vision is what you can see when you look straight ahead. It is the vision you use when you read or watch TV.3

Types of Vision Loss
This picture is provided to show 2 main types of vision, and not to show or suggest actual or possible vision loss, which can vary from patient to patient and in severity.

Sabril and Permanent Vision Loss

People who take Sabril do not lose all their vision. Some may lose peripheral vision (the ability to see to the side when you look straight ahead), or have blurry vision. Some people can have severe vision loss, particularly to their peripheral vision. If this happens, it will not get better.2

With severe vision loss, you may only be able to see things straight in front of you (sometimes called "tunnel vision"). See the Eye Care Action Plan.

Adults Taking Sabril

If you are an adult taking Sabril, you need to tell your doctor right away if you:

  • Think you are not seeing as well as before you started taking Sabril
  • 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

These changes can mean that you have damage to your vision.2 If you drive and your vision is damaged by Sabril, driving might be more dangerous, or you may not be able to drive safely at all. You should discuss this with your doctor.

Infants Taking Sabril

Parents or caregivers of babies taking Sabril are not likely to pick up on the symptoms of vision loss in babies until it is severe. Doctors may not find vision loss in babies until it is severe.2

Timing for Vision Loss

Your doctor needs to monitor your vision or your baby’s vision closely while on Sabril, because there is no way to predict who will experience vision loss or when it may occur. For some people, it develops within a few weeks after starting treatment. It can also occur any time during treatment, even after months or years, and there is no dose that is free from risk of vision loss. However, taking higher doses or taking Sabril for a longer period of time may increase the risk. There is a possibility that vision loss can worsen despite stopping Sabril as well.2

It is important that you tell your doctor if you or your baby has ever had any vision problems, as well as any other medicines you or your baby take. Sabril and other medicines may affect each other, causing side effects.2

Testing for Vision Loss

The only way to know for sure if you or your baby is developing vision loss is to have vision tests. Your doctor will recommend the test or tests to have. Most of the tests will be done by an eye doctor. This doctor might use one or more of the following eye tests - or another test not listed here - to find out if you or your baby is developing permanent vision loss.

  • Eye chart: Your doctor might ask you to read letters in different sizes to see how good your overall vision is4
  • Confrontation test: In this quick and basic test, the eye doctor moves a hand across your face, and you will be asked to tell when you see it5
  • Static perimetry: A type of visual field test that measures your peripheral (side) vision for each eye. While your head is still and you are looking straight ahead, a device with fixed light sources run by a computer flashes lights of varying brightness, and you will be asked to push a button when you can see them6,7
  • Kinetic perimetry: A type of visual field test that measures your peripheral (side) vision for each eye. While your head is still and you are looking straight ahead, a technician uses a moving light source of a particular size and brightness, and you will be asked to indicate when you can see it6,7
  • Electroretinography (also called ERG): In this procedure, a tiny electrode is placed right on the eye to sense and record how the eye changes as a light flashes8
  • Optical coherence tomography (also called OCT): In this test, the machine scans your eyes and processes the scan into a picture for your doctor9

These vision tests cannot prevent or lessen the vision damage that can happen with Sabril, but they do allow you to stop Sabril if vision has gotten worse, which usually will lessen further damage.

References:
  1. Sabril full Prescribing Information/CPS. Lundbeck.
  2. Sabril full Prescribing Information/IS. Lundbeck.
  3. Common types of low vision. American Optometric Association website. http://www.aoa.org/x5244.xml. Accessed June 22, 2009.
  4. Comprehensive eye and vision examination. American Optometric Association website. http://www.aoa.org/x4725.xml. Accessed September 2, 2009.
  5. U.S. National Library of Medicine. National Institutes of Health. Visual Field. http://www.nlm.nih.gov/medlineplus/ency/article/003879.htm. Updated January 21, 2009. Accessed September 11, 2009.
  6. Module 12: Visual field testing, section 1: Basic concepts. Eyetec.net website. http://eyetec.net/group3/m12s1.htm. Accessed September 15, 2009.
  7. Sheppard J. Visual field test. MedicineNet website. http://www.medicinenet.com/visual_field_test/article.htm. Updated December 7, 2007. Accessed September 15, 2009.
  8. Kriss A, Russell-Eggitt I. Electrophysiological assessments of visual pathway function in infants. Eye. 1992;6:145-153.
  9. Pedut-Kloizman T, Pakter HM, Schuman JS, et al. Ophthalmic diagnosis using optical coherence tomography. Ophthalmol Clin North Am. 1998;11(3):465-486.

Sabril® (vigabatrin) Tablets
Sabril® (vigabatrin) for Oral Solution

Use

SABRIL Tablets is a prescription medicine used along with other treatments to treat adults with complex partial seizures (CPS) if the CPS does not respond well enough to several other treatments, and if you and your doctor decide the possible benefit of taking SABRIL is more important than the risk of vision loss. SABRIL should not be the first medicine used to treat your CPS.

SABRIL for Oral Solution is a prescription medicine used to treat babies 1 month to 2 years old who have infantile spasms (IS) if you and your doctor decide that the possible benefits of SABRIL are more important than the possible risk of vision loss.

Important Safety Information

WARNING: VISION LOSS
See Medication Guide for complete information

In all people who take SABRIL:

  • You are at risk for vision loss with any amount of SABRIL
  • Your risk of vision loss may be higher the more SABRIL you take daily and the longer you take it
  • It is not possible for your doctor to know when vision loss will happen. It could happen soon after starting SABRIL or any time during treatment. It may even happen after treatment has stopped

SABRIL can permanently damage the vision of anyone who takes it. The most noticeable loss is in the ability to see to the side when looking straight ahead (peripheral vision). If this happens, it will not get better. People who take SABRIL do not lose all of their vision, but some people can have severe loss particularly to their peripheral vision. With severe vision loss you may only be able to see things straight in front of you (sometimes called ‘tunnel vision’). You may also have blurry vision.

Because of the risk of vision loss, in adults SABRIL is used to treat CPS only in people who do not respond well enough to several other medications. Tell your doctor right away if you think you are not seeing as well as before you started taking SABRIL; start to trip, bump into things, or are more clumsy than usual; or are surprised by people or things coming in front of you that seem to come out of nowhere. These changes can mean that you have damage to your vision. Your doctor will test your visual fields (including peripheral vision) and visual acuity (ability to read an eye chart) before you start SABRIL or within 4 weeks after starting SABRIL, and at least every 3 months after that until SABRIL is stopped. Even if your vision seems fine, it is important that you get these regular vision tests because damage can happen to your vision before you notice any changes. These vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow you to stop SABRIL if vision has gotten worse, which usually will lessen further damage. If you do not have these vision tests regularly, your doctor may stop prescribing SABRIL for you. You should also have a vision test after SABRIL is stopped.

Because of the risk of vision loss, SABRIL is used in babies (1 month to 2 years of age) with IS only when you and your doctor decide that the possible benefits of SABRIL are more important than the possible risks. Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Doctors may not find vision loss in babies until it is severe. It is difficult to test vision in babies, but all babies should have a vision test before starting SABRIL or within 4 weeks after starting SABRIL, and every 3 months after that until SABRIL is stopped. You should have a vision test for your baby after SABRIL is stopped. Tell your doctor right away if you think that your baby is not seeing as well as before taking SABRIL or is acting differently than normal. Even if your baby’s vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision tests may not show the damage to your baby’s vision before it is serious and permanent. If your baby does not have these vision tests regularly, your doctor may stop prescribing SABRIL for your baby. If your baby is not able to complete vision testing, your doctor may continue prescribing SABRIL for your baby. But, your doctor will not be able to watch for vision loss in your baby.

Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given SABRIL. It is not known if these changes are harmful.

Like other antiepileptic drugs, SABRIL may cause suicidal thoughts or actions in a very small number of people. Call a doctor right away if you have any symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worry you. Do not stop SABRIL without first talking to a healthcare provider. Stopping SABRIL suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures.

If you are an adult with CPS, tell your doctor about all of your medical conditions including if you have or ever had depression, mood problems, suicidal thoughts or behavior, an allergic reaction to SABRIL, any vision problems, any kidney problems, low red blood cell counts, any nervous or mental illness, or any other medical condition. If you are breastfeeding or plan to breastfeed, SABRIL can pass into breast milk and may harm your baby. If you are pregnant or plan to become pregnant, it is not known if SABRIL will harm your unborn baby. You and your healthcare provider will have to decide if you should take SABRIL while you are pregnant.

Before giving SABRIL to your baby, tell the doctor about all of your baby’s medical conditions including if your baby has or ever had an allergic reaction to SABRIL, or any vision or kidney problems.

Tell your doctor about all the medicines you or your baby take. SABRIL causes sleepiness and tiredness. Adults taking SABRIL should not drive, operate machinery, or perform any hazardous task, unless you and your doctor have decided that you can do these things safely. SABRIL can cause serious side effects in adults such as low red blood cell counts, sleepiness and tiredness, nerve problems, weight gain that happens without swelling, and swelling. It is not known if these side effects also happen in babies who take SABRIL. SABRIL may make certain types of seizures worse. You should tell your or your baby’s doctor right away if the seizures get worse.

The most common side effects of SABRIL in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking, joint pain, memory problems and not thinking clearly, and eye problems such as blurry vision, double vision, and eye movements you cannot control. The most common side effects of SABRIL in babies and young children include: sleepiness — some babies may have a harder time suckling and feeding or may be irritable — ear infection, and irritability. Tell your doctor if you or your baby has any side effect that bothers you or that does not go away. These are not all of the possible side effects of SABRIL. For more information, ask your doctor or pharmacist.

Oral Solution: For more information, please see the full Prescribing Information including Boxed Warning, Medication Guide and Dosing Instructions.

Solución oral: Para más información, vea por favor la información que prescribe completa incluyendo la advertencia encajonada, guía de la medicación y las instrucciones de la dosificación.

Tablets: For more information, please see the full Prescribing Information including Boxed Warning and Medication Guide.

Tabletas: Para más información, vea por favor la información que prescribe completa incluyendo la advertencia encajonada y guía de la medicación.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The product information provided in this site is intended only for residents of the U.S. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. Sabril may not be a fit for everyone. You and your doctor should decide if the possible benefits of taking Sabril are more important than the risk of permanent vision loss.

Note: All patients shown on this website were taking Sabril when they were photographed and/or videotaped.