Posts Tagged ‘Depakote’

Antiepileptic Drugs and Suicidality (August 2009)

Thursday, August 20th, 2009

Video originally created by FDA -- posted by Lawsuit.com on August 10, 2009

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.

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Depakote Warning: Children Have Lower IQ’s

Wednesday, May 13th, 2009

Study results published in the New England Journal of Medicine have demonstrated that depakote, aka Valproate, used during pregnancy may result in the child having a lower IQ. Depakote has also been associated with a high rate of fetal death and birth defects such as spina bifida in children of mothers who used Depakote. The study was performed by Dr. Kimford Meador of Emory University and a team of researchers.

Depakote is used to treat epileptic seizures, mood disorders and migraine headaches. The study followed pregnant women in the U.S. and England that had taken anti-seizure medications between 1999 and 2004.The study compared the IQ scores of children by 3 years of age whose mothers had taken one of four types of anti-seizure medications, including: depakote, lamotrigine (also known as lemectal), phenytoin, and carbamazepine. The study results showed that Depakote children ranked six to nine points lower on the IQ scale when compared to children whose mothers took other anti-seizure medications. The average IQ for a “Depokote child” was 92. The IQ ranges of the other children were between 98 and 101. The average rating for a child’s intelligence is 100. The study results also demonstrated that the higher the dosage that the “Depakote mother” received, the lower the IQ the child had. Dosage levels were irrelevant in the other anti-seizure medications.

In 2007, Meader study results presented at the American Academy of Neurology showed a marked risk for retardation in children whose mothers had taken Depakote. This rate of risk was twice as great as the risk associated with other anti-seizure medications. Twenty four percent of the children who mother took depakote and participated in Meador’s study had an IQ level that is associated with retardation.

According to the Alliance for Human Resource Protection, approximately 25,000 U.S. children are born to women who have epilepsy annually. It is important to note that just because the other anti-seizure medications are not associated with an elevated risk for lower IQ’ed children, does not mean that there are not other types of risks for injury. For example, there have been reports that lemectal is associated with Steven’s Johnson Syndrome, a life threatening and severely debilitating condition.

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