Side Effects

Please read the Medication Guide that comes with your prescription before you or your child start taking Sabril® (vigabatrin) and each time you get a refill, as there may be new information. This Medication Guide, however, does not take the place of talking with your doctor about your (or your child's) medical condition or treatment.

This is not all the important safety information you should know about Sabril. For more information about safety and side effects, please do the following:

Permanent Vision Loss

An important side effect you need to 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. The risk of vision loss may be higher the more Sabril is taken daily and the longer you take it. This side effect has occurred in 3 of 10 or more of patients taking Sabril. If vision loss occurs, it will not get better.

The most noticeable loss is in your ability to see to the side when you look straight ahead (peripheral vision). 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.

Tell your doctor 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

Tell your healthcare provider right away if you think that your baby is:

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

It is recommended that your doctor monitor your (or your child'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 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.

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.

Additional Sabril Warnings, Precautions, and Side Effects

MRI Changes in Infants

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.

Risk of Suicidal Thoughts or Actions

Like other antiepileptic drugs, Sabril may cause suicidal thoughts or actions. Call a doctor right away if you (or your child) have any of the following symptoms:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behavior or mood

Watch for the early symptoms of suicidal thoughts and actions:

  • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts or feelings
  • Keep all follow-up visits with your doctor as scheduled
  • Call your doctor between visits as needed, especially if you are worried about symptoms

Suicidal thoughts or actions can be caused by things other than medicines. If you or your child has suicidal thoughts or actions, your healthcare provider may check for other causes.

Sudden Withdrawal

Do not stop Sabril without talking with your doctor first. 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. Follow your healthcare provider's instructions on how to stop taking Sabril.

Tell your healthcare provider right away about any increase in seizures when Sabril treatment is being stopped. Before your child starts taking Sabril, speak to your child's healthcare provider about what to do if your baby misses a dose, vomits, spits up, or only takes part of the dose of Sabril.

Additional Serious Side Effects

Sabril can cause serious side effects, including:

  • Sleepiness and tiredness. Adults taking Sabril should not drive, operate machinery, or perform any hazardous task, unless you and your healthcare provider have decided that you can do these things safely
  • Sabril may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable.
  • Weight gain that happens without swelling

The following serious side effects happen in adults. It is not known if these side effects also happen in babies who take Sabril:

  • Low red blood cell counts (anemia)
  • Nerve problems. Symptoms of a nerve problem can include numbness and tingling in your toes or feet. It is not known if nerve problems will go away after you stop taking Sabril
  • Swelling

Sabril may make certain types of seizures worse. Tell your doctor right away if seizures get worse.

Most Common Side Effects

In adults, the most common side effects of Sabril include:

  • Problems walking or feeling uncoordinated
  • Feeling dizzy
  • Shaking (tremors)
  • Joint pain
  • Memory problems and not thinking clearly
  • Eye problems (blurry vision, double vision, and eye movements that you cannot control)

In children 10 to 16 years of age, the most common side effects of Sabril include:

  • Weight gain
  • Upper respiratory tract infection
  • Tiredness
  • Aggression
  • Also expect side effects like those seen in adults

The most common side effects of Sabril in babies include:

  • Sleepiness — Sabril may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable
  • Swelling in the bronchial tubes (bronchitis)
  • Ear infection
  • Irritability

Tell your doctor if you (or your child) have any side effect that bothers you or that does not go away. These are not all the possible side effects of Sabril.

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, 1 month to 2 years old, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.

IMPORTANT
SAFETY INFORMATION

EXPAND

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.

IMPORTANT
SAFETY INFORMATION

COLLAPSE

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 Vigabatrin 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, tiredness, 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 Guidefull Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use.

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

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.

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Sabril is a registered trademark of Lundbeck