Numerous clinical studies on Stavzor (delayed release valproic acid) and pregnancy have shown that the drug may cause birth defects in humans. These problems could be very severe, and pregnant women should not take the medication unless absolutely necessary (such as for treating epilepsy). If you are already taking Stavzor and pregnancy occurs, notify your healthcare provider right away.
Is Stavzor Safe During Pregnancy?
Stavzor™ (delayed release valproic acid) may not be safe for women who are pregnant, although sometimes the benefits may outweigh the possible risks, depending on the condition being treated and the severity of the condition. In studies that looked at the effects of Stavzor during pregnancy, the drug caused birth defects and other problems.
Stavzor and Pregnancy Categories D and X
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Stavzor is in pregnancy Category D when used for the treatment of epilepsy or manic episodes associated with bipolar disorder. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Stavzor is in pregnancy Category X when used for the prevention of migraine headaches. Pregnancy Category X means that the risks of taking the medication during pregnancy clearly outweigh the benefits. Medications in this category should not be taken by women who are pregnant or planning on becoming pregnant. Women who are taking Stavzor for this reason and become pregnant or plan on becoming pregnant should contact their healthcare provider before stopping the medication, as this medication should not be stopped abruptly.
Numerous studies have demonstrated that Stavzor may cause birth defects in humans. These birth defects can be very severe, and pregnant women should not take Stavzor unless absolutely necessary. For instance, it is not a good idea to take Stavzor during pregnancy for migraine prevention, since migraines are not a life-threatening condition.
However, uncontrolled epilepsy can be dangerous to both a pregnant woman and the fetus. Some pregnant women with epilepsy may need to stay on Stavzor during pregnancy (see Epilepsy and Pregnancy for more information about pregnant women with epilepsy).
You and your healthcare provider must discuss the specific benefits and risks of using Stavzor during pregnancy in your particular situation. If your epilepsy is very mild (or if you have not had a seizure in several years), you may consider stopping Stavzor. However, if your epilepsy is severe or difficult to control, it may be best for you to stay on Stavzor. No matter what, do not stop taking Stavzor suddenly.
If you and your healthcare provider decide that it is best for you to continue taking Stavzor, you will need frequent blood tests to measure your Stavzor levels. Pregnancy can affect the way your body handles Stavzor, and it is important to keep your dose at the lowest effective level (to help protect your fetus). Your healthcare provider may suggest a higher-than-usual dose of folic acid, as this may also help protect the fetus.
Food and Drug Administration, Center for Drug Evaluation and Research. Valproate anti-seizure products: drug safety communication -- contraindicated for pregnant women for prevention of migraine headaches (5/6/2013). FDA Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350868.htm?source=govdelivery. Accessed May 15, 2013.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 7th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2005.
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