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Generic Name: valproic acid

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A fatty acid derivative anticonvulsant - used for Seizure

FDA Alerts

Special Alerts:

[Posted 01/31/2008] 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. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

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What is the most important information I should know about valproic acid?

In rare cases, valproic acid has caused life-threatening liver failure, especially in children younger than 2 years old. Children of this age may be at even greater risk for liver problems if they use more than one seizure medication, if they have a metabolic disorder, or if they have a brain disease causing mental impairment (such as Creutzfeldt-Jacob disease, Huntington disease, multiple sclerosis, or a brain injury or infection).

Valproic acid has also caused rare cases of life-threatening pancreatitis (inflammation of the pancreas). Pancreatitis can come on suddenly and symptoms may start even after you have been taking valproic acid for several years.

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis. Valproic acid can cause birth defects. Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.