Depakote

Suicidal Behavior Linked to Antiepileptic Drugs

January 31, 2008—The FDA issued a warning about an increased risk of suicidal thoughts and behavior associated with eleven drugs used to treat epilepsy, as well as psychiatric disorders and other conditions. Suicidal behavior included completed suicides, as well as suicide attempts and acts in preparation of suicide.

Examining approximately 200 clinical trials involving 44,000 patients, the FDA concluded that patients taking antiepileptic drugs had twice the risk of suicidality than patients taking a placebo. Suicidal ideation and behavior were observed as early as one week after starting the antiepileptic drug and continued though 24 weeks of use.

The following antiepileptic drugs were included in the FDA’s analysis:

• Topamax (topiramate)
  
• Lyrica (pregabalin)
  
• Depakote, Depakote ER, Depakene, Depacon (valproate)
  
• Carbatrol, Equetrol, Tegretol, Tegretol XR (carbamazepine)
  
• Felbatol (felbamate)
  
• Neurontin (gabapentin)
  
• Lamictal (lamotrigine)
  
• Keppra (levetiracetam)
  
• Oxcarbazepine (trileptal)
  
• Gabitril (tiagabine)
  
• Zonegran (zonisamide)
  

In addition to the eleven drugs included in the analysis, the FDA expects that the increased risk of suicidal thoughts and behavior is shared by all antiepileptic drugs, and anticipates a class-wide labeling change.

Twenty Percent of pregnancies exposed to Depacon, Depakote, and Depakene resulted in fetal death or babies born with birth defects

According to a study, the epilepsy drug commonly marketed as Depacon, Depakote, and Depakene (Valproate) has been linked to an increased risk for fetal death and birth defects.

The study published in the September 2006 issue of the journal Neurology, reported that over 20 percent of the pregnancies exposed to Valproate (Depacon, Depakote, and Depakene) resulted in fetal death or babies born with birth defects, including:

• skull and limb deformities
  
• brain, heart, and lung problems
  

Valproate, manufactured by Abbott Laboratories, is also used for some psychiatric conditions, bipolar, and headaches.

The study, conducted by Kimford Meador, a fellow at the American Academy of Neurology and of the University of Florida in Gainesville , compared four commonly used epilepsy medications – Valproate, Phenytoin, Carbamazepine, and Lamotrigine. Of the four, Valproate was determined to pose the greatest risk to the fetuses of pregnant women.

The incidence of these problems was lower for the other drugs tested in the study, which examined 333 pairs of mother and child

The study's author recommends that doctors talk with their patients about the risks associated with Valproate, especially women of child-bearing age.

Note - Do not change medications without first consulting your doctor.

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