FDA Safety Information
Warning on Antiepileptic Drugs
Antiepileptic Drugs: FDA informed healthcare professionals
that the Agency has analyzed reports of suicidality (suicidal behavior or
ideation) from placebo- controlled clinical studies of 11 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 11
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.
Health care 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. Many physiatrists use these antiepileptic medications to treat
neuropathic pain and should, therefore, be aware of these possible effects.
Read the complete MedWatch
2008 Safety Summary.
Click here to learn about other
MedWatch notifications.
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