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Information for Healthcare
Professionals
Tiagabine hydrochloride (marketed as Gabitril)
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.
To
report any unexpected adverse or serious events associated with the
use of this drug, please contact the FDA MedWatch program at
1-800-FDA-1088 or
http://www.fda.gov/medwatch/report/hcp.htm
Information for Healthcare Professional Sheet on suicidality and antiepileptic drugs: www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.
Recommendations
Prescribers with patients taking Gabitril or who are considering
prescribing the drug should consider the following:
-
The off-label use of Gabitril is strongly
discouraged.
-
The use of Gabitril for any indication other than
for partial seizures in patents with epilepsy who are least 12 years
old is an off-label use, meaning the evidence to support safety and
effectiveness for those uses has not been approved by the FDA.
-
In non-epileptic patients who develop seizures while
on Gabitril treatment, Gabitril should be discontinued and patients
should be evaluated for an underlying seizure disorder.
-
The Gabitril dosing recommendations in current
labeling for treatment of epilepsy were based on use in patients
with partial seizures 12 years of age and older, most of whom were
taking enzyme-inducing antiepileptic drugs (AEDs; e.g.,
carbamazepine, phenytoin, primidone and phenobarbital), which lower
plasma levels of Gabitril by inducing its metabolism. Use of
Gabitril without enzyme-inducing antiepileptic drugs results in
blood levels about twice those attained in the studies on which
current dosing recommendations are based. Use in non-induced
patients requires lower doses of Gabitril. These patients may also
require a slower titration of Gabitril compared to that of induced
patients (see full Prescribing Information).
Data Summary
There have been more than 30 postmarketing reports of new onset
seizures and status epilepticus in patients without epilepsy in
association with Gabitril use. In most of these cases, Gabitril was
used as an off-label treatment for a psychiatric illness. In some
cases, the prescriber had continued to treat with, or increased the
dose of, Gabitril, presumably unaware of the possibility that
Gabitril could cause seizures. Dose may be an important predisposing
factor in the development of seizures, although seizures have been
reported in patients taking daily doses of Gabitril as low as 4
mg/day. In most cases, patients were using concomitant medications
(antidepressants, antipsychotics, stimulants, narcotics) that are
thought to lower the seizure threshold. Some seizures occurred near
the time of a dose increase, even after periods of prior stable
dosing.
Report serious adverse events to FDA's MedWatch at
1-800-FDA-1088; or
http://www.fda.gov/medwatch/report/hcp.htm
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov
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Date created: February 18, 2005, updated January 31, 2008 |
