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Tiagabine hydrochloride
(marketed as Gabitril) Information
FDA ALERT [1/31/2008] - The FDA has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. These drugs are commonly referred to as antiepileptic drugs (see the list below). In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed. The relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
All patients who are currently taking or starting on any antiepileptic drug should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. More information
FDA ALERT [2/18/2005] – Seizures in
Patients Without Epilepsy
Today the Food and Drug Administration
announced that a bolded Warning will be added to the labeling
for Gabitril (tiagabine) to warn prescribers of the risk of
seizures in patients without epilepsy being treated with this
drug. Although Gabitril has been shown to reduce the frequency
of seizures in patients with epilepsy, paradoxically,
Gabitril’s use has been associated with the occurrence of
seizures in patients without epilepsy. Gabitril is approved for
use only as adjunctive therapy in adults and children 12 years
and older in the treatment of partial seizures. Because
Gabitril has not been systematically evaluated in adequate and
well-controlled trials for any other indication, its safety and
effectiveness have not been established for any other use.
Cephalon will undertake an educational campaign to discourage
off-label use of Gabitril.
This information reflects FDA’s preliminary analysis of data
concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information. FDA intends to update this
sheet when additional information or analyses become available.
- Healthcare Professional
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Date created: February 18, 2005, updated January 31, 2008 |
