Other Side Effects of Sabril (vigabatrin)

WARNING: PERMANENT VISION LOSS
See full Prescribing Information for complete boxed warning

  • SABRIL causes progressive and permanent bilateral concentric visual field constriction in a high percentage of patients. In some cases, SABRIL may also reduce visual acuity
  • Risk increases with total dose and duration of use, but no exposure to SABRIL is known that is free of risk of vision loss
  • Risk of new and worsening vision loss continues as long as SABRIL is used, and possibly after discontinuing SABRIL
  • Baseline and periodic vision assessment is recommended for patients on SABRIL. However, this assessment cannot always prevent vision damage
  • SABRIL can cause permanent vision loss. SABRIL is available only through a restricted program called the SABRIL REMS Program

Click the links below to learn more about side effects of Sabril:

Permanent Vision Loss

Sabril (vigabatrin) 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, patients may only be able to see things straight in front of them (sometimes called "tunnel vision"). They may also have blurry vision.

Tell your patients to inform you right away if they:

  • Think they are not seeing as well as before starting on Sabril
  • Start to trip, bump into things, or are more clumsy than usual
  • Are surprised by people or things coming in front of them that seem to come out of nowhere

Because of the risk of vision loss, Sabril is used to treat refractory complex partial
seizures (CPS) only in people who do not respond well enough to several other medicines. Click here to learn more about vision loss with Sabril.

Other Warnings and Precautions

MRI Abnormalities in Infants

  • Abnormal magnetic resonance imaging (MRI) signal changes have been observed in some infants treated for IS with SABRIL. These changes generally resolved with discontinuation of treatment, and resolved in a few patients despite continued use
  • Caregiver(s) should be informed of the possibility that infants may develop an abnormal MRI signal of unknown clinical significance

Suicidal Behavior and Ideation

Like other antiepileptic drugs, Sabril (vigabatrin) may increase the risk of suicidal thoughts or behaviors. Patients should be monitored for the following:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling agitated or restless
  • Panic attacks
  • 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. Patients, their caregivers, and families should be counseled that antiepileptic drugs may increase the risk of suicidal thoughts and behavior. They should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Withdrawal of Sabril Therapy

Sabril should be withdrawn gradually. However, if withdrawl is needed because of a serious adverse event, rapid discontinuation can be considered. Patients and caregivers should be told not to suddenly discontinue Sabril therapy. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in patients who are being treated for seizures.

Other Serious Side Effects

These other serious side effects have been seen with Sabril:

  • Anemia
  • Somnolence and Fatigue. Patients should be advised not to drive, operate machinery, or perform any hazardous task until they are familiar with the effects of Sabril on their ability to perform such activities
  • Sleepy babies may have a harder time suckling and feeding, or may be irritable
  • Peripheral Neuropathy
  • Weight gain that happens without edema
  • Edema

Most Common Adverse Reactions

The most common adverse reactions in controlled studies (≥5% over placebo) include:

  • Adults >16 years of age:
    • Fatigue
    • Somnolence
    • Nystagmus
    • Tremor
    • Blurred vision
    • Memory impairment
    • Weight gain
    • Arthralgia
    • Abnormal coordination
    • Confusional state

  • Pediatrics 10 to 16 years of age:
    • Increased weight
    • Upper respiratory tract infection
    • Tremor
    • Fatigue
    • Aggression
    • Diplopia

In infants, the most common adverse reactions in a controlled clinical study (incidence >5%) were:

  • Somnolence
  • Bronchitis
  • Ear infection
  • Acute otitis media

This is not all the Important Safety Information for Sabril. For more information about safety and side effects, please:

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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.



SABRIL ® (vigabatrin) Tablets and Powder for Oral Solution

Indications and Usage

SABRIL (vigabatrin) is indicated as adjunctive therapy for patients 10 years of age and older with refractory complex partial seizures (CPS) who have
inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. SABRIL is not indicated as a first line agent for CPS.

SABRIL (vigabatrin) is indicated as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss.


Important Safety Information

WARNING: PERMANENT VISION LOSS
See full Prescribing Information for complete boxed warning.

  • SABRIL can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, SABRIL may also reduce visual acuity.
  • Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to SABRIL known to be free of risk of
    vision loss.
  • Risk of new and worsening vision loss continues as long as SABRIL is used, and possibly after discontinuing SABRIL.
  • Baseline and periodic vision assessment is recommended for patients on SABRIL. However, this assessment cannot always prevent
    vision damage.
  • SABRIL is available only through a restricted program called the SABRIL REMS Program.
  • SABRIL can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. SABRIL also can damage the central retina and may decrease visual acuity.
  • Risk of new or worsening vision loss continues as long as SABRIL is used, and is not reversible. The onset of vision loss is unpredictable and can occur soon after starting treatment, at any time during treatment, even after months or years, or possibly after discontinuation. Symptoms of vision loss from SABRIL are unlikely to be recognized by patients or caregivers before it is severe. Vision loss of milder severity may still adversely affect function.
  • Vision assessment is recommended at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months during therapy, and 3 to 6 months after discontinuing therapy. Even with frequent monitoring, some patients will develop severe vision loss. Consider drug discontinuation, balancing benefit and risk, if vision loss is documented.
  • Because of the risk of permanent vision loss, withdraw SABRIL from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation, and from patients with infantile spasms within 2 to 4 weeks of initiation, or sooner, if treamtent failure becomes obvious. Periodically reassess patient response and continued need of SABRIL.
  • Do not use SABRIL in patients with, or at high risk of, other types of irreversible vision loss, or, with other drugs associated with serious adverse opthalmic effects, unless the benefits clearly outweigh the risks.
  • Use the lowest dosage and shortest exposure to SABRIL that is consistent with clinical objectives. Adjust the dose in patients with renal impairment.
  • Abnormal magnetic resonance imaging (MRI) signal changes have been observed in some infants treated for IS with SABRIL. These changes generally resolved with discontinuation of treatment, and resolved in a few patients despite continued use.
  • Antiepileptic drugs (AEDs), including SABRIL, increase the risk of suicidal thoughts and behavior. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
  • As with all AEDs, discontinue SABRIL gradually to avoid withdrawal seizures. However, if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.
  • SABRIL can cause anemia, peripheral neuropathy, weight gain, and edema. SABRIL can cause somnolence and fatigue. Advise patients not to drive or operate machinery until they know how SABRIL will affect them.
  • Do not use SABRIL during pregnancy unless the potential benefit justifies the risk to the fetus. Pregnancy Registry: To provide information regarding the effects of in utero exposure to SABRIL, physicians should recommend that pregnant patients taking SABRIL enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Patients must call the toll-free number 1-888-233-2334 to enroll. Registry information can be found at http://www.aedpregnancyregistry.org/
  • Vigabatrin is excreted in human milk and may cause serious adverse events in nursing infants. Discontinue nursing or discontinue SABRIL, taking into account the importance of the drug to the mother.
  • The most common adverse reactions in controlled studies (≥5% over placebo) include: Adults>16 years of age with CPS: fatigue, somnolence, nystagmus, tremor, blurred vision, memory impairment, weight gain, arthralgia, abnormal     coordination, and confusional state Pediatrics 10 to 16 years of age with CPS: weight gain, upper respiratory tract infection, tremor, fatigue, aggression, and diplopia Infants with IS: somnolence, bronchitis, ear infection, and acute otitis media

For more information, please see SABRIL full Prescribing Information including Boxed Warning for risk of permanent vision loss, Medication Guide, 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.