FDA MedWatch - Antiepileptic Drugs - FDA Analysis Showed P...

[Guest guest]

Note: This may be of interest given that Gabapentin

(marketed as Neurontin) and Pregabalin (marketed as Lyrica)

are often used in our patient community for pain management.]

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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.

Read the complete 2008 MedWatch Safety Summary including a link to

the Healthcare Professional Sheet regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic

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