Precautions and Warnings With Vigabatrin

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• Depression
• A history of suicidal thoughts or behaviors
• Anemia
• Kidney disease, such as kidney failure or renal failure
• Congestive heart failure (CHF)
• Any allergies, including to foods, dyes, or preservatives.

• Pregnant or thinking of becoming pregnant
• Breastfeeding.

• Vigabatrin has a high risk for causing permanent vision loss, especially loss of peripheral vision. Due to this risk, vigabatrin should only be used in situations where the benefits outweigh this risk. Because of this risk, regular vision checks will be necessary, even for young babies. A vision check should be done within four weeks of starting vigabatrin and at least every three months thereafter (except in certain situations, such as with blind individuals).

• Prescribers and pharmacists must be registered with the special restricted distribution program for this medication (the "SHARE" program) before prescribing or dispensing this medication. This program is designed to help ensure that only appropriate individuals receive this medication and that appropriate vision monitoring is performed. Patients must also be enrolled in the SHARE program.

• Be aware that parents and even healthcare providers may not be able to notice vision problems in young babies until the vision loss is severe.

• Studies suggest that seizure medications may increase the risk of suicide. Make sure to watch for any unusual behaviors or mood changes, and be sure your family and friends know to keep an eye out for such problems.

• In studies, vigabatrin sometimes caused changes in the brain (as seen on an MRI). It is not yet clear how important these changes are. Some of the infants who had these brain changes also had abnormal development in motor skills; however, this might have been coincidental.

• In animal studies, vigabatrin caused nerve problems in the brain. It is unclear if these problems will occur in humans as well.

• Vigabatrin can cause anemia. Your healthcare provider may want to monitor you for this problem.

• This medication can cause drowsiness, dizziness, and coordination problems. You may want to see how the drug affects you before driving or operating heavy machinery.

• Vigabatrin can cause peripheral neuropathy (nerve problems in the extremities). Typically, this occurs as numbness or tingling in the feet and toes.

• As with all seizure medications, you should not stop taking vigabatrin suddenly, as this can make seizures worse.

• If you have kidney problems, you will probably need a lower-than-usual vigabatrin dosage.

• Vigabatrin can cause water retention. However, vigabatrin-related water retention does not appear to be related to the usual risks associated with water retention, such as high blood pressure or congestive heart failure.

• This drug can cause weight gain. However, if the medication is working, this is a relatively minor side effect. Weight gain can occur without water retention and is not necessarily related to water retention.

• Vigabatrin may react with a few other medications (see Drug Interactions With Vigabatrin).

• Vigabatrin is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Sabril and Pregnancy).

• Vigabatrin passes through breast milk in humans. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Sabril and Breastfeeding).