Permanent Vision Loss and Sabril

An important side effect parents need to know is that Sabril (vigabatrin) 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 3 out of 10 or more of patients taking Sabril. If vision loss occurs, it will not get better.1

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.2

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

Sabril (vigabatrin) can damage the vision of anyone who takes it. The most noticeable loss is in your ability to see to the side when you look 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. See the Eye Care Action Plan.

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.1

Tell your doctor right away if you think your baby is:

  • Not seeing as well as before taking Sabril
  • Acting differently than normal

Timing for Vision Loss

Your doctor needs to monitor your baby’s vision closely while on Sabril (vigabatrin), because there is no way to predict who will experience vision loss or when it may occur. For some, it develops within a few weeks after starting treatment or sooner. 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.1

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

Testing for Vision Loss

Even if your baby’s vision seems fine, it is important that your baby get these regular vision tests because damage can happen to their vision before you notice any changes. The only way to know if your baby is developing vision loss is to have vision tests. For timing of vision tests, see the Eye Care Action Plan in the next section. 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 your baby is developing permanent vision loss:

  • Visual acuity testing: This type of test measures the eye’s ability to see details at near and far distances and usually involves reading letters or looking at symbols of different sizes on an eye chart. Several types of visual acuity tests may be used3
  • Confrontation testing: In this simple, preliminary test, the eye doctor faces the infant and attracts his or her attention. An assistant then shows a toy or light to the side, as the doctor watches for your baby to respond to the toy or light3
  • Electroretinography (also called ERG): In this procedure, a tiny sensor is placed on the eye, and eye activity is measured in response to a flash of light. This testing option usually requires infants and young children to be sedated4
  • Optical coherence tomography (also called OCT): This noncontact, noninvasive and painless imaging technique scans the eyes and processes them into images in a short time for the doctor5

These vision tests cannot prevent or lessen the vision damage that can happen with Sabril (vigabatrin), but they do allow you to stop Sabril if vision has gotten worse.

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SABRIL ® (vigabatrin) Tablets and Powder for Oral Solution

Use

SABRIL (vigabatrin) is a prescription medicine used with other treatments in adults and children 10 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments and if the possible benefits outweigh the risk of vision loss. SABRIL should not be the first medicine used to treat CPS.

SABRIL (vigabatrin) is a prescription medicine used in babies, 1month to 2 years old, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.


Important Safety Information

WARNING: PERMANENT VISION LOSS
See Medication Guide and full Prescribing Information for complete information.


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 healthcare provider 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.
  • Because SABRIL might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the SABRIL Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you.
  • SABRIL can damage the vision of anyone who takes it. People who take SABRIL do not lose all of their vision, but some people can have severe loss particularly to their ability to see to the side when looking straight ahead (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. If this happens, it will not get better.
  • Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting 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; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.
  • It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting SABRIL, and at least every 3 months during treatment until SABRIL is stopped. It is also recommended that vision be tested about 3 to 6 months after SABRIL is stopped. It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
  • Vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow SABRIL to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
  • If vision tests are not done regularly, your healthcare provider may stop prescribing SABRIL for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing SABRIL, but will not be able to watch for any vision loss.
  • 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 and actions in some people. Call a healthcare provider right away if you (or your child) 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 seizures that will not stop.
  • SABRIL can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because SABRIL causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. SABRIL may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
  • Before starting SABRIL, tell your doctor about all of your (or your child’s) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to SABRIL, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illness. Tell your doctor about all the medicines you (or your child) take.
  • 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.
  • The most common side effects of SABRIL in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking (tremor), joint pain, memory problems and not thinking clearly, and eye problems like blurry vision, double vision, and eye movements that cannot be controlled. The most common side effects of SABRIL in children 10 to 16 years of age include weight gain, upper respiratory tract infection, tiredeness, and aggression. Also expect side effects like those seen in adults.
  • The most common side effects of SABRIL in babies include: sleepiness—some babies may have a harder time suckling and feeding or may be irritable, swelling in the bronchial tubes (bronchitis), ear infection, and irritability.
  • Tell your healthcare provider if you or your child have 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 healthcare provider or pharmacist.

For more information, please see SABRIL Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use; or call toll-free 1-888-457-4273.

Consulte la Información de prescripción completa de SABRIL, incluido el recuadro de advertencia para conocer los riesgos de pérdida permanente de visión, la Guía del medicamento y las Instrucciones de uso; o llame al número gratuito 1-888-457-4273.

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.

REFERENCES:

  1. Sabril full Prescribing Information. Lundbeck.
  2. Common types of low vision. American Optometric Association website. http://www.aoa.org/x5244.xml. Accessed February 13, 2014.
  3. Vision tests. WebMD Web site. http://www.webmd.com/eye-health/vision-tests. Accessed February 13, 2014.
  4. Kriss A, Russell-Eggitt I. Electrophysiological assessments of visual pathway function in infants. Eye. 1992;6:145-153.
  5. Pedut-Kloizman T, Pakter HM, Schuman JS, et al. Ophthalmic diagnosis using optical coherence tomography. Ophthalmol Clin North Am. 1998;11(3):465-486.