Rachel Warren

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The US Food and Drug Administration (FDA) has announced that the children of mothers who took medications including or related to valproate sodium during pregnancy show decreased IQ scores, and that these drugs are now contraindicated for pregnant women.

Contraindicated valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.

While valproate-containing medicines already have a boxed warning for fetal risk, the FDA’s strengthened recommendations are based on the results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, which showed that children exposed to valproate products in utero had decreased IQ at age 6 when compared to children who were exposed to other antiepileptic drugs. The IQ difference varied between 8 and 11 points.

Valproate products have several FDA-approved uses, including the prevention of migraine headaches, treatment of epilepsy seizures, and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder). For bipolar disorder and seizures valproate may have value in pregnant women, but it should only be taken if other medications have not controlled the symptoms or are otherwise unacceptable.

“Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use,” said Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA is working with manufacturers to make changes to the drug labels to reflect the new information and change the pregnancy category for prevention of migraine headaches to category X (the drug’s risks outweigh the drug’s benefits for this use) from category D (the drug’s benefits outweigh the drug’s risks for this use). Valproate products will remain category D for the other two approved indications-epilepsy and manic episodes associated with bipolar disorder.

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The US Food and Drug Administration has announced that the children of mothers who took medications including or related to valproate sodium during pregnancy show decreased IQ scores, and that these drugs are now contraindicated for pregnant women.

FDA Contraindicates Migraine Treatments for Pregnant Women

The US Food and Drug Administration (FDA) announced that it has approved an application submitted by Teva Women’s Health to market the emergency contraceptive Plan B One-Step (levonorgestrel) for use without a prescription by women 15 years of age and older. In December 2011, Teva had submitted an application to make Plan B One-Step available over the counter (OTC) to all girls of reproductive age, however at that time the FDA did not approve the application.

This approval is based on an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually transmitted diseases. The FDA stated that “Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product.” To prevent theft, a security tag will be placed on all product cartons of Plan B One-Step.

“Research has shown that access to emergency contraceptive products has  the potential to further decrease the rate of unintended pregnancies in  the United States,” said FDA Commissioner Margaret A. Hamburg, MD. “The  data reviewed by the agency demonstrated that women 15 years of age and  older were able to understand how Plan B One-Step works, how to use it  properly, and that it does not prevent the transmission of a sexually  transmitted disease.”

Besides Plan B One-Step, there are currently two other emergency contraceptive drugs available in the United States: Plan B and ella. Plan B is a prescription contraceptive that is available from generic manufacturers for women over the age of 17. It is comprised of two doses of levonorgestrel (.75 mg in each tablet) taken 12 hours apart. Ella (ulipristal) also requires a prescription, and prevents pregnancy when taken orally within 5 days after unprotected sexual intercourse.

Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus.

The FDA has approved an application to market the emergency contraceptive Plan B One-Step for use without a prescription by women 15 years of age and older.

Author | Rachel Warren

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