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Generic Name: gabapentin

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A gamma-aminobutyric acid analog - treats Epilepsy and Postherpetic Neuralgia

FDA Alerts

Special Alerts:

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency 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. 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. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

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Gabapentin
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G 5026 100 mg	G 5027 300 mg	G 21 600 mg	G 5028 400 mg
NEURONTIN 800 800 mg	Neurontin 400 mg / PD 400 mg	Neurontin 100 mg / PD 100 mg	NEURONTIN 600 600 mg
Neurontin 300 mg / PD 300 mg

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(GA ba PEN tin)

What is the most important information I should know about gabapentin?

You should not use this medication if you are allergic to gabapentin.

Before taking gabapentin, tell your doctor if you have kidney, liver, or heart disease.

You may have thoughts about suicide while taking gabapentin. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking gabapentin for seizures without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking gabapentin suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking gabapentin.

Carry an ID card or wear a medical alert bracelet stating that you are taking gabapentin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

What is gabapentin?

Gabapentin is an anti-epileptic medication, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain.

Gabapentin is used alone or in combination with other medications to treat seizures caused by epilepsy in adults and children who are at least 12 years old. Gabapentin is also used with other medications to treat partial seizures in children who are 3 to 12 years old.

Gabapentin is also used to treat nerve pain caused by herpes virus or shingles (herpes zoster).

Gabapentin may also be used for other purposes not listed in this medication guide.

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