-----Original Message-----
From: U.S. Food & Drug Administration (FDA) [mailto:[log in to unmask]]

Sent: Thursday, January 31, 2008 14:42
To: [log in to unmask]
Subject: FDA MedWatch- Antiepileptic Drugs- FDA Analysis Showed Patients
Receiving Antiepileptic Drugs Had Approximately Twice The Risk of Suicidal
Behavior Or Ideation

 MedWatch logo< http://www.fda.gov/medwatch/images/mw_logo_ani_160px.gif>
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
<http://www.fda.gov/medwatch/images/mw-mast-tag2.gif> 	

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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