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.
The following drugs can interact with gabapentin. Tell your doctor if you are using any of
these:
hydrocodone (Lortab, Vicodin, Vicoprofen, and others);
morphine (Kadian, MS Contin, Oramorph, and others); or
naproxen (Naprosyn, Aleve, Anaprox, and others).
This list is not complete and there may be other drugs that can interact
with gabapentin. Tell your doctor about all the prescription and over-the-counter medications
you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other
doctors. Do not start using a new medication without telling your doctor.
Get emergency medical help if you have any of these signs of an allergic
reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth;
difficulty breathing; swelling of your face, lips, tongue, or throat.
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.
Call your doctor at once if you have any of these serious side effects:
increased seizures;
fever, chills, body aches, flu symptoms;
swelling of your ankles or feet;
confusion;
rapid back and forth movement of your eyes;
tremor; or
easy bruising.
Some side effects are more likely in children taking
gabapentin. Contact your doctor if the child taking this medication has any of the
following side effects:
changes in behavior;
memory problems;
trouble concentrating; or
acting restless, hostile, or aggressive.
Less serious side effects may include:
dizziness, drowsiness, weakness, tired feeling;
lack of coordination;
blurred vision;
nausea, vomiting, stomach pain, loss of appetite;
diarrhea, constipation;
dry mouth;
runny or stuffy nose, sore throat;
headache;
sleep problems (insomnia), unusual dreams; or
acne, mild skin rash.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect.
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