CJF Reports on Alternatives to Controversial Epilepsy Treatments (Topamax and Depakote) During Pregnancy

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Epilepsy treatments like Topamax and Depakote have recently come under heavy scrutiny for allegedly leading to a variety of birth defects, ranging from cleft lip and palate to life-altering neural tube defects like spina bifida. The FDA has repeatedly urged physicians to warn women of childbearing age about the birth defect risks associated with such epilepsy treatments during pregnancy. The Consumer Justice Foundation provides further information about the pregnancy risks for women taking these antiepileptic medications, as well as the legal rights of women whose children have been harmed by these drugs during pregnancy at http://www.topamaxbirthinjury.com.

According to new studies ("The Teratogenicity of Anticonvulsant Drugs", nejm.org), infants born to women who take antiepileptic and anticonvulsant drugs during pregnancy have an increased risk of being born with one or more major birth defects. For pregnant women with epilepsy, seizure treatment poses significant risks, as the benefits of some treatments may actually be outweighed by the potential risks.

Fortunately, there are relatively safe treatment options available for pregnant women, and new information about minimizing the risks of antiepileptic drugs and how to adjust them during pregnancy to promote healthy outcomes for both mother and child. The Consumer Justice Foundation reports on alternatives to recently controversial antiepileptic drugs like Topamax and Depakote, which may pose serious risks to the fetus when taken during pregnancy.

Topamax is an antiepileptic drug manufactured by Ortho-McNeil Pharmaceutical, a division of Johnson & Johnson. Topamax (topiramate) was approved by the FDA in 1996 for the treatment of epilepsy, and again in 2004 for the prevention of migraine headaches. According to a 2008 study published in the journal Neurology, infants exposed to topiramate in utero were eleven times more likely to develop oral clefts and fourteen times more likely to develop genital defects like hypospadias, compared to infants whose mothers received no antiepileptic treatment while pregnant (“Topiramate in pregnancy: Preliminary experience from the UK Epilepsy and Pregnancy Register”). According to new information provided by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, infants born to women who take Topamax during pregnancy may have a twenty-times increased risk of suffering from cleft lip or cleft palate, compared to unexposed infants ("Topamax and Pregnancy", epilepsy.emedtv.com). After reviewing this information, the FDA elevated the pregnancy category of Topamax from C to D (fda.gov).

Depakote is an antiepileptic drug manufactured by pharmaceutical company, Abbott Laboratories. Depakote (valproic acid) has been on the market since 1983 and has been approved to treat epilepsy, migraine headaches, seizures and bipolar disorder. Recent Depakote birth defect information indicates that infants whose mothers take Depakote while pregnant have an increased risk of suffering severe birth defects, including neural tube defects like spina bifida, cardiovascular birth defects and craniofacial defects like cleft lip and cleft palate ("Birth Defects Related to Depakote and Similar Drugs", fda.gov). In fact, a New England Journal of Medicine study published in 2010 indicated that babies exposed to Depakote and other valproic acid medications during the first trimester of pregnancy were 12.7 times more likely to develop spina bifida compared to unexposed infants (“Valproic Acid Monotherapy in Pregnancy and Major Congenital Malformations”). In 2011, the FDA issued an additional safety announcement warning patients and healthcare professionals about the increased risk of lower cognitive test scores than children exposed to other antiepileptic medications during pregnancy (fda.gov; Valproate Information).

Although a number of studies have focused on the immediate effects of antiepileptic drugs like Topamax and Depakote on exposed infants, little is known about the long-term consequences of fetal exposure to antiepileptics. In light of these issues, the Epilepsy Foundation has called for more research on pregnancy and long-term effects of all newer antiepileptic drugs (epilepsyfoundation.org). In the meantime, women can increase their chances of a successful pregnancy by working with their doctors to determine the best choice of medication, reviewing antiepileptic risks and benefits with their physicians, discussing medication changes before pregnancy begins, taking folic acid and vitamin supplementation before and during pregnancy, having medication levels monitored during pregnancy, avoiding abrupt termination of an antiepileptic, and keeping current on emerging antiepileptic research (epilepsyfoundation.org).

Several Depakote class action lawsuits have already been filed by Depakote attorneys against Abbott Laboratories, on behalf of parents across the country who believe their children were possibly affected by the drug (St. Clair County Circuit Court Case No.10-L-651, 11-L-27 & 11-L-143). These class actions allege that Abbott was aware of the pregnancy risks associated with Depakote and allegedly failed to accurately inform consumers in the US, while simultaneously misleading doctors and patients by downplaying these known risks.Topamax lawsuits may be filed by Topamax lawyers on behalf of families that may have been affected by birth defects allegedly caused by Topamax use in pregnancy, especially in light of the FDA's recent reclassification of Topamax as a pregnancy category D medication. Many Topamax attorneys are reviewing potential cases for free all across the United States

About the Consumer Justice Foundation:

The Consumer Justice Foundation can help educate women on the risks of pharmaceuticals during pregnancy as well as help mothers whose children have been affected by antiepileptic medications like Topamax and Depakote by connecting them with professionals experienced in seeking financial compensation for the long-term medical expenses required by children born with birth defects.

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Faith Anderson
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