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Sabril / Vigabatrin

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1Sabril / Vigabatrin Empty Sabril / Vigabatrin Wed Sep 30, 2009 10:48 am

TJW

TJW
Admin

Sabril (SAY-bril) is a brand name used by Aventis for its seizure medicine. The generic name is vigabatrin (vi-GAY-buh-trin). This medication has recently been approved by the Food and Drug Administration (FDA) in the United States, but it has been available in other countries for many years.

Sabril was developed by a research laboratory in France in 1977. Unlike many other seizure medicines, which are discovered by accident, it was purposely developed with a specific plan in mind—preventing the breakdown of GABA, a neurotransmitter that inhibits brain activity. Sabril was first marketed in Europe in the late 1980s and was approved in Australia in 1993 and in Canada in 1994.

Sabril (vigabatrin), although not officially approved in the United States because of concerns about vision problems, is useful in controlling partial seizures and some other specific seizure types. Many randomized controlled studies in both Europe and the United States have confirmed this effectiveness, which appears to continue for most patients during long-term treatment.

Studies of children with partial epilepsy have had results similar to the studies of adults.

In one American study, various doses of Sabril were given as add-on therapy to 174 people who had complex partial seizures (with or without secondary generalization) that were not well controlled by other seizure medicines. About half of the people who took 3 grams or more of Sabril per day had at least 50% fewer seizures.

A similar study using 3 grams per day of Sabril reported that 43% of patients had at least a 50% reduction in seizure frequency, compared to 19% of those who took a placebo in addition to their other medication. There were few problems with side effects.

A few studies have compared Sabril with carbamazepine (Tegretol or Carbatrol) used alone to treat patients with newly diagnosed partial seizures. Most have concluded that carbamazepine is more effective for this purpose but fewer patients from the Sabril group drop out because of side effects.

Sabril also may be effective in treating infantile spasms, especially those related to cerebral malformations or tuberous sclerosis, with fewer side effects than other treatments such as ACTH.

Sabril appears to be ineffective in controlling primary generalized seizures, including absence seizures and myoclonic seizures. Most studies have had poor results using it for Lennox-Gastaut syndrome, especially if myoclonic seizures are prominent.

Sabril (vigabatrin) typically has few unwanted side effects. Because it is usually taken along with another seizure medicine, however, it can be difficult to be sure which effects result from each type of medicine.

In a study of more than 2000 adults, the two most common side effects were:

drowsiness (reported by 12.5%)
fatigue (reported by 9%)

Other side effects reported even less often included:

irritability and nervousness
dizziness
headache
depression
weight gain

The side effect most often mentioned in children taking Sabril is some form of hyperactivity, which was reported in 11% of 299 children in one study. These children were also taking other seizure medicines at the same time. Problems reported in children less often included sleepiness, insomnia, weight gain, and fatigue.

A few people with epilepsy have more seizures when they take Sabril. This most often happens with people who have myoclonic seizures.

If side effects do not go away within several days or are really bothersome, call the doctor. Sometimes the doctor can help by changing the prescription:

reducing the overall amount of Sabril
changing the amount taken at certain times, such as taking a greater proportion of the Sabril at bedtime to reduce daytime sleepiness
prescribing smaller doses, to be taken more often

No one should stop taking Sabril or change the amount they take or when they take it without their doctor's guidance.

People who have just started taking Sabril (or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.

Long-term side effects
As many as 25% of people who take Sabril over a long period develop irreversible damage to the retina that limits their field of vision (the area they can see when looking straight ahead). For this reason, special visual testing at regular intervals is often recommended.

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