Antiepileptic Drugs and Suicidality

FDA is alerting healthcare professionals that the labeling for antiepileptic drugs will now warn that patients taking these drugs have an increased risk of suicidal thoughts and actions.

The warnings are based on FDA's analysis of placebo-controlled clinical studies of eleven drugs used to treat epilepsy, psychiatric disorders and other conditions. In this analysis, the risk was approximately doubled in patients receiving the anti-epileptic drugs compared with those getting placebo: 0.43% vs. 0.22%.

The following drugs were included in the analyses:

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)

The increased risk was seen as early as one week after starting therapy and continued through 24 weeks. And it was generally consistent for all eleven drugs in the analysis, and across a range of indications. This suggests that this risk applies to all antiepileptic drugs when they're used for any indication - even those that weren't part of the analysis.

Healthcare professionals should closely monitor all patients starting or taking antiepileptic drugs. They should be alert to changes in behavior that could signal an emerging or worsening of depression or suicidal thoughts or behavior. Patients will also be given Medication Guides explaining these risks each time their prescriptions are dispensed.

FDA Patient Safety News: August 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=89#7

Category:

Education

Tags:

• Epilepsy
• FDA
• drug
• suicide
• suicidal behavior
• adverse effect
• warning

[Nguli34689]

Phenobarbital is still one of the best.

[Interactivesystems]

oh right... maybe thats why im fucked ..Im on two of them....