Important Information for Women Who Could Become Pregnant About the Use
of Stavzor (valproic acid) Delayed Release Capsules
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
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 babies.
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 doctor.
Information For Women Who Become Pregnant
If you become pregnant while taking valproate, you should contact your doctor
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 take 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 Stavzor (valproic acid) delayed release capsules 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
Important Safety Information You Should Know about STAVZOR
Liver problems Your doctor should check your liver function before you start taking STAVZOR and at frequent intervals while you're on therapy. If you feel generally ill (malaise), weak, and tired, if your face is swollen and you lose your appetite, and start vomiting, call your doctor immediately.
Pregnancy: Birth defectsWomen who can become pregnant need to know that valproic acid has been associated with birth defects, in particular with spina bifida, a condition in which the baby's spinal canal fails to close. If you are planning to become pregnant, you should discuss the risks of birth defects, along with other possible treatment options, with your doctor. If you do become pregnant while taking STAVZOR, call your doctor immediately.
Read more important safety information about pregnancy.
PancreatitisSome people taking valproate have experienced a serious, life-threatening illness called pancreatitis (inflamed pancreas). If you experience stomach pain, nausea, vomiting, and/or loss of appetite, call your doctor immediately.
Common side effects reported in studies with valproate were nausea, drowsiness, vomiting, and dizziness. These are not all the side effects that may occur. You will find a complete list of side effects in the full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Recent Information about Antiepileptic Medications including STAVZOR® (valproic acid) Delayed Release Capsules for any use
For Patients and Caregivers
All antiepileptic medicines, used for any condition, may increase suicidal thoughts or actions in some patients. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Watch for and call the healthcare provider right away to report if you or your family member see the appearance or worsening of symptoms of depression, any unusual changes in mood or behavior, or the appearance of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to the healthcare provider.
For Healthcare Professionals
All antiepileptic drugs (AEDs), including STAVZOR, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Anyone considering prescribing Stavzor or any other AED must balance their risk of suicidal thoughts and behavior with the risk of untreated illness.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and 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 healthcare providers.
For medical inquiries specific to Stavzor, please call 1-800-455-8070