A new study warning released by the Food and Drug Administration (FDA) states that taking the epilepsy medication Topamax while pregnant increases the risk of oral cleft birth defects like cleft palate and cleft lip.
The research uncovers data which suggests that the risk of those oral cleft birth defects when taking Topamax during pregnancy increases by as much as 16 times.
If you or a loved one took Topamax during pregnancy and have had a child suffering from a birth defect, you may be entitled to compensation through a Topamax birth defects lawsuit.
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Topamax has been approved by the Food and Drug Administration (FDA) to treat seizures associated with epilepsy and to aid in the prevention of migraines. In some cases, however, doctors may prescribe Topamax in an off-label manner to treat things like obesity, bipolar disorder, and alcoholism.
According to Russel Katz, MD, the director of the Division of Neurology Products in the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, “Health care professionals should carefully consider the benefits and risks of Topamax when prescribing it to women of childbearing age. Alternative medications that have a lower risk of birth defects should be considered.”
Utilizing data taken from the North American Antiepileptic Drug Pregnancy Registry, the Food and Drug Administration (FDA) states that 1.4% of children who were exposed to Topamax during pregnancy developed a cleft palate or cleft lip, compared to approximately .4% of those who were exposed to other epilepsy medications during pregnancy. For infants whose mothers don’t take any type of epilepsy medication during pregnancy, the incidence of cleft palate and cleft lip is much lower (.07%).
Similar data has appeared in studies conducted in European countries.
Higher Pregnancy Warning By The FDA
Because of the recently surfaced information about Topamax potentially causing oral cleft birth defects, the Food and Drug Administration (FDA) has declared that Topamax must have a stronger caution on its label. Topamax has been changed from a pregnancy category C drug to a pregnancy category D drug. Pregnancy category C means that there has been data suggesting fetal damage in animal studies but that there is not enough data in human studies. Category D means that there has been adequate data in human studies to suggest that Topamax may cause fetal damage.
Oral cleft birth defects such as cleft palate and cleft lip happen when portions of the lip or palate are not properly fused together during the first trimester of pregnancy. The severity of oral cleft birth defects may range from being minor, like a small notch in the lip, to a large groove that goes into the roof of the mouth and nose which may lead to issues with eating, talking, and even ear infections.
Food and Drug Administration workers suggest that pregnant women and women who are at a childbearing age should consider other treatment options and discuss them with their doctors before taking Topamax. Women who take Topamax should let their doctor know immediately when they are pregnant or considering becoming pregnant.
Topamax Birth Defect Lawsuits: Speak to an Attorney
Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The antidepressant Topamax may be linked to causing the development of birth defects in unborn babies, infants, and children when their mothers took antidepressants while pregnant.
Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Topamax cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an antidepressant like Topamax during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).