Drug Notebook

FDA Alerts

    Hepatotoxicity
  • Potentially fatal hepatic failure can occur.
  • Usually occurs during the initial 6 months of therapy.
  • Children <2 years of age are at considerably increased risk of developing fatal hepatotoxicity, especially those receiving multiple anticonvulsants and those with congenital metabolic disorders, severe seizure disorders accompanied by mental retardation, or organic brain disease.
  • Use with extreme caution in such children and only as single-agent therapy; weigh carefully benefits versus risks.
  • Above this age group, the risk of fatal hepatotoxicity decreases considerably in progressively older patient groups.
  • Serious fatal hepatotoxicity may be preceded by symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.
  • In epileptic patients, loss of seizure control also may precede its development.
  • Monitor patients closely for development of any such changes.
  • Perform liver function tests prior to and at frequent intervals during therapy, especially during the first 6 months.

    Fetal/Neonatal Morbidity and Mortality
  • Can produce teratogenic effects (e.g., neural tube defects such as spinal bifida).
  • Use in women of childbearing potential requires that potential benefits of therapy be weighed against the risk of fetal injury. (See Pregnancy under Cautions.)

    Pancreatitis
  • Life-threatening pancreatitis has occurred both in children and adults.
  • Some cases described as hemorrhagic with rapid progression from initial symptoms to death.
  • Can occur shortly after initial use as well as after several years of use.
  • Warn patients and caregivers that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.
  • Usually discontinue the drug and initiate alternative therapy if pancreatitis is diagnosed.

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valproic acid
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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.

What is valproic acid?

Valproic acid affects chemicals in the body that may be involved in causing seizures.

Valproic acid is used to treat various types of seizure disorders. Valproic acid is sometimes used together with other seizure medications.

Valproic acid may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking 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. Do not take valproic acid if you have liver disease or a urea cycle disorder.

Before taking valproic acid, tell your doctor if you have:

If you have any of these conditions, you may not be able to use valproic acid, or you may need a dosage adjustment or special tests during treatment.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use valproic acid without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Valproic acid can cause birth defects. Use an effective form of birth control while you are using this medication. Valproic acid passes into breast milk and could harm a nursing infant. Do not take valproic acid without telling your doctor if you are breast-feeding a baby.
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