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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

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
  • 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, or call 1-800-FDA-1088.