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The US Food and Drug Administration (FDA) has warned that some anti-seizure medication, such as valproate sodium, can have a negative affect upon the cognitive abilities of children born to mothers taking the medication during pregnancy.
Related products such as valproic acid and divalproex sodium also came under fire in the new FDA guidelines, submitted on June 30.
Epidemiologic studies (of children at three-years-old and then between the ages of five and 16) showed that children performed less well on cognitive tests (like IQ tests) if their mothers had taken valproate sodium (or related products) during pregnancy than if they had taken other anti-seizure medication.
The long-term effects of the anti-seizure drugs upon cognitive development are unknown, while it is also uncertain whether these effects occur when foetal exposure is limited to less than the full duration of pregnancy.
The FDA has produced the following guidelines for healthcare professionals.
1. Inform women of childbearing age of the increased risk for adverse effects on cognitive development with prenatal valproate exposure.
2. Continue to counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy.
3. Weigh the benefits and risks of valproate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of adverse birth outcomes should be considered. Healthcare professionals should discuss the relative risks and benefits of appropriate alternative therapies.
4. Know that untreated or inadequately treated epilepsy or bipolar disorder during pregnancy increases the risk of complications in both the pregnant mother and her developing baby.
5. Recommend use of effective contraception for women who are not planning a pregnancy if the decision is made to prescribe valproate to women of childbearing age.
6. Inform patients of the North American Antiepileptic Drug Pregnancy Registry and encourage patients who become pregnant to enroll by calling 1-888-233-2334.
7. Report adverse events involving valproate to the FDA MedWatch program at www.fda.gov/medwatch.