Divalproex Sodium ER
Prescription Divalproex Sodium ER Drug Information17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (17.8)
Patients and guardians should be warned that nausea, vomiting, abdominal pain, anorexia, diarrhea,
asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical
evaluation promptly [see Warnings and Precautions (5.1)].
Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can
be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see
Warnings and Precautions (5.3)].
17.3 Teratogenicity/Usage in Pregnancy
Use of valproate during pregnancy increases the risk for neural tube defects and other malformations.
Female patients of child-bearing age, who require therapy for epilepsy, bipolar disorder, or migraines,
should be advised of the risks of valproate use during pregnancy and appropriate therapeutic options.
This is particularly important when the treatment of a spontaneously reversible condition not ordinarily
associated with permanent injury or risk of death (e.g. migraine) is considered. Patients should read
the Patient Information Leaflet, which appears as the last section of the labeling [see Use in Specific
Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant.
This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To
enroll, patients can call the toll free number 1-888-233-2334 [see Use in Specific Populations (8.1)].
17.4 Suicidal Thinking and Behavior
Patients, their caregivers, and families should be counseled that AEDs, including Depakote ER, may
increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for
the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior,
or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern
should be reported immediately to the healthcare providers [see Warnings and Precautions (5.5)].
Patients should be informed of the signs and symptoms associated with hyperammonemic
encephalopathy and be told to inform the prescriber if any of these symptoms occur [see Warnings
and Precautions (5.7, 5.8)].
17.6 CNS depression
Since valproate products may produce CNS depression, especially when combined with another CNS
depressant (e.g., alcohol), patients should be advised not to engage in hazardous activities, such as
driving an automobile or operating dangerous machinery, until it is known that they do not become
drowsy from the drug.
17.7 Multi-organ Hypersensitivity Reaction
Patients should be instructed that a fever associated with other organ system involvement (rash,
lymphadenopathy, etc.) may be drug-related and should be reported to the physician immediately
[see Warnings and Precautions (5.10)].
17.8 FDA–Approved Patient Labeling
Important Information for Women Who Could Become Pregnant About the Use of Depakote ER
(divalproex sodium) extended release tablets.
Please read this leaflet carefully before you take any of this medication. This leaflet provides a
summary of important information about taking this medication to women who could become
pregnant. If you have any questions or concerns, or want more information about this medication,
contact your doctor or pharmacist.
Information For Women Who Could Become Pregnant
You can only obtain this medication by prescription from your doctor. The decision to use this
medicine should be made by you and your doctor based on your health needs and medical condition.
Before starting this medicine, you should know that using this medicine during pregnancy causes an
increased chance of birth defects in your baby. These birth defects may include spina bifida and other
defects where the spinal canal does not close normally. These defects usually occur in 1 to 2 out of
every 1000 babies born in the United States. Studies show that for babies born to epileptic women
who took valproate in the first 12 weeks of pregnancy, these defects occur in 1 to 2 out of every 100
Use of valproate during pregnancy also increases the chance of other birth defects such as of the
heart, bones, and other parts of the body. Studies suggest that other medicines used to treat your
condition may be less likely to cause these defects.
Information For Women Who Are Planning to Get Pregnant
Women using valproate who plan to get pregnant should discuss their treatment options with their
Information For Women Who Become Pregnant
If you become pregnant while taking valproate, you should contact your doctor immediately.
Other Important Information
• You should take your medicine exactly as prescribed by your doctor to get the most
benefit from your medicine and reduce the risk of side effects.
• If you have taken more than the prescribed dose, contact your hospital emergency room
or local poison center immediately.
• Your medicine was prescribed for your particular condition. Do not use it for another
condition or give the drug to others.
Facts About Birth Defects
It is important to know that birth defects may occur even in children born to women who are not taking
any medicines and do not have other risk factors.
This summary provides important information about the use of Depakote ER (divalproex sodium)
extended release tablets to women who could become pregnant. If you would like more information,
ask your doctor or pharmacist to let you read the professional labeling and then discuss it with them.
If you have any questions or concerns about taking this medication, you should discuss them with
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