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This is a summary of the most important information
about Gabitril. For details, talk to your healthcare professional.
FDA ALERT
� [02/18/2005] � FDA and the Maker of Gabitril are Discouraging
the Use of Gabitril to Treat Conditions Other than Epilepsy.
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Seizures have occurred in patients taking Gabitril for conditions
other than epilepsy
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Most of the seizures that have occurred in patients without a
history of epilepsy have occurred soon after starting Gabitril, or
soon after a dose increase. Some seizures occurred after several
months of treatment. Some patients had seizures at a very low dose
of Gabitril.
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Gabitril is only approved for use with other anti-epilepsy
medicines to treat partial seizures in adults and children 12
years and older
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If you are taking Gabitril, you should not stop the drug on your
own; you should speak to your healthcare professional about this
as soon as you can.
The label for Gabitril has been changed to warn healthcare
professionals and patients that these seizures can occur in
patients without epilepsy.
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.
What is Gabitril?
Gabitril is an anti-epilepsy (seizure) drug. Gabitril is used
together with other anti-epilepsy drugs to treat partial seizures in
adults and children 12 years and older
Who Should Not Take
Gabitril?
Healthcare professionals are allowed
to, and sometimes do, prescribe drugs for uses that are not in the
labeling. The maker of Gabitril is strongly discouraging Gabitril's
use for any condition except for epilepsy because most of the
reported seizures with Gabitril occurred in patients being treated
for other conditions. However, if you are taking Gabitril for a
condition other than epilepsy, you should not stop taking it on your
own; you should speak to your healthcare professional as soon as you
can.
What Are The Risks?
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Seizures in patients without
epilepsy: See FDA Alert.
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Withdrawal seizures. Gabitril
can increase seizures if it is stopped suddenly in patients with
epilepsy. If you have epilepsy, and your healthcare professional has
decided that you should stop taking Gabitril, it should be stopped
slowly.
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Thinking and concentration
problems, sleepiness and tiredness. Do not drive a car or
operate dangerous machines until you know how Gabitril affects you.
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Serious rash. Gabitril may
cause a serious and life-threatening rash.
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Other side effects include
dizziness, lightheadedness, low energy, nausea, nervousness,
irritability, tremors, and stomach pain.
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Tell your healthcare professional
about any medical conditions you have, especially liver problems.
Tell your healthcare professional if you are pregnant, planning to
become pregnant, or breast-feeding
Are There Any Interactions With
Drugs or Foods?
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Gabitril may interact with other
medicines. Tell your healthcare professional about all medicines,
vitamins, and herbal supplements you take, especially other
medicines used for epilepsy.
How Do I Take Gabitril?
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