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.