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Diagnosis & Treatment > Seizure Medications > Sabril > What are the most serious side effects of Sabril?
 

What are the most serious side effects of Sabril?

Most people who take Sabril (vigabatrin) have no side effects or mild side effects that go away with no lasting harm. But a few people have serious reactions.

The best-known serious problem with Sabril is irreversible damage to the retina of the eye, causing a visual-field defect in up to 25% of people (more in some studies) who take Sabril for a long time. This potential problem may be a reason not to use Sabril if there are good alternatives. If you do use Sabril, you should have regular examinations to look for such damage before it becomes too far advanced.

Here's a list of symptoms that may be the start of other serious problems. If you notice any of these symptoms, call your doctor right away:

  • "Psychiatric side effects" (paranoia, delusions, depression)
  • Worsening of seizures
  • An allergic reaction (difficulty breathing, closing of the throat, hives, or swelling of the lips, tongue, or face)

The psychiatric effect of Sabril requires further study. The incidence of depression and psychotic reactions in patients taking Sabril is not high but may be slightly higher than in other patients with epilepsy. These disorders are probably more likely to occur in patients who have a history of psychiatric illness. In past studies, they have generally disappeared when the medication was stopped.

Sabril is effective in treating a wide variety of seizures, but when used for some disorders, it is possible that Sabril can cause more seizures to occur. Patients with generalized seizures, including tonic-clonic seizures and myoclonic seizures, should be aware of this risk. In one fairly small study, 20% of children with refractory epilepsy experienced a seizure increase. Further study is needed to determine how much of this effect is just due to chance.

As with many other seizure medicines, there is a very small chance of developing a rash so serious that hospitalization may be required. Though the risk is small, call the doctor promptly if you notice a rash, since in a few cases these rashes are fatal.

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

  • Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
  • Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
  • Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
  • Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
    • Talking or thinking about wanting to hurt yourself or end your life
    • Withdrawing from friends and family
    • Becoming depressed or having your depression get worse
    • Becoming preoccupied with death and dying
    • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Reviewed July 2008 by Steven C. Schachter, MD, epilepsy.com Editorial Board.

When a patient presents with a serious and/or unexpected adverse reaction from a medication or device, you should consider reporting this event to Medwatch (http://www.fda.gov/medwatch/report/hcp.htm). To download Medwatch reporting forms click here (http://www.fda.gov/medwatch/getforms.htm).

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