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Important Safety Update
For patients with partial seizures, prescribe with confidence.
Because GABITRIL has...
- NO Black box warning
- NO Scheduled drug status
- NO Changes in pharmacokinetic and dynamic properties in the presence of ethanol*1
- NO Significant interactions observed with oral contraceptives, cimetidine, theophylline, warfarin,
triazolam,* or digoxin
- NO Clinically significant effect on steady-state plasma levels of phenytoin, carbamazepine,
valproate, phenobarbital,† or primidone†
- NO Specific recommendations for routine laboratory monitoring
GABITRIL Offers Targeted Action With A Proven Safety Profile2
- Adverse events were usually mild to moderate in intensity
- Low discontinuation rate due to adverse events (11% vs 6% in placebo)
Most common adverse events — GABITRIL (N=494) in combination
with other anticonvulsants vs placebo (N=275)2 |
| Adverse Events |
GABITRIL |
Placebo |
| Dizziness/lightheadedness‡ |
27% |
15% |
| Asthenia‡/lack of energy |
20% |
14% |
| Somnolence |
18% |
15% |
| Nausea |
11% |
9% |
| Nervousness‡/irritability |
10% |
3% |
| Tremor‡ |
9% |
3% |
| Abdominal pain |
7% |
3% |
| Abnormal thinking/difficulty with concentration or attention‡ |
6% |
2% |
- Cognitive side effects were mild to moderate
The GABITRIL package insert was updated in February 2005 to incorporate new important safety information regarding new
onset seizures in patients without epilepsy. The following warning has been added:
Postmarketing reports have shown that GABITRIL has been associated with new onset seizures and status epilepticus in
patients without epilepsy. 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) considered to lower the seizure threshold. Some seizures
have been observed near the time of a dose increase, even after periods of prior stable dosing.
In nonepileptic patients who develop seizures while on GABITRIL treatment, GABITRIL should be discontinued and
patients should be evaluated for an underlying seizure disorder. Other important changes were added to the
Pharmacokinetics, Overdosage, and Dosage & Administration sections of the P.I.
Cephalon is committed to educating healthcare professionals about these changes to the P.I. and to ensure the appropriate prescribing of GABITRIL.
As with other anticonvulsants in the treatment of epilepsy, GABITRIL should be withdrawn gradually to minimize the potential of
increased seizure frequency unless safety concerns require a more rapid withdrawal.
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