FDA news for pregnant women

  1. Found this while doing some research and thought it was rather encouraging. So many women (and men, really) have ugly side effects from AEDs. Its good to see a seizure disorder treatment that won't put a fetus at risk. Anyway, I thought it might be of interest here.

    New FDA Approved Device Labeling Offers Improved Care for Women with Epilepsy

    WASHINGTON, April 2 /PRNewswire/ -- Women with epilepsy who worry that their current therapy poses a risk to their unborn offspring are encouraged by the recent U.S. Food and Drug Administration action concerning the lack of teratogenic effects in one form of therapy. The agency approved a change in labeling for VNS Therapy to inform women and their physicians that abnormal physical or developmental effects were not observed in offspring during animal studies.

    VNS Therapy involves an implanted device that stimulates the brain through tiny electrical impulses transmitted through the vagus nerve. The device is implanted near the collarbone with a subcutaneous lead to the nerve at the side of the neck.

    "Pregnant women with epilepsy have a critical need to know how epilepsy therapies may impact the physical development of their child," said Eric Hargis, Epilepsy Foundation president and CEO. "The Epilepsy Foundation welcomes this clear and positive change in labeling of VNS Therapy and the expanded understanding of this treatment that it reflects. It should help guide women and their doctors in making informed decisions about choosing the best epilepsy treatment options."

    There are approximately one million women of childbearing age with epilepsy in the United States. More than 90 percent of babies born to these women are normal healthy children. However, the risk of having a child with birth defects among women with the disorder is two to three times greater than for women in the general population.

    The Epilepsy Foundation, with national offices in metropolitan Washington, D.C., and a network of affiliates throughout the nation, is the leading non- profit volunteer organization devoted to research, education, advocacy, and the provision of services in the community for people with seizure disorders and their families.
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  3. by   emily_mom
    This came out too late for my friend, who suffered through her pregnancy with not knowing. She has the implant, through the trials, and has been better, although still having seizures almost daily. She just got a seizure dog...which is great!

    Thankfully, her baby is OK (as far as we know).
  4. by   RosieGlow
    I am sorry to hear for your friend who had to worry like that. I've heard (though have not had it confirmed) that it can be a toss up as to weather AEDs or seizures are worse for a growing fetus. Either way, its a lot of pressure to put on a woman trying to stay healthy and have a healthy baby. I'm glad the VNS option is out there for them as a way to ease their minds.
  5. by   HazeK
    neat data....
    will look into it more.

    finally a non-pharmocological help for pregnant epileptics!