Topamax Birth Defect Lawyer
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Our Topamax® birth defect attorneys are available to investigate lawsuits for parents of babies that are born with birth defects. To schedule a free and confidential consultation, please contact us today.
Topamax® Causes Birth Defects
Topamax® (topiramate) can cause birth defects if taken during the first trimester of a woman’s pregnancy, according to the U.S. Food and Drug Administration (FDA). Topamax® is prescribed to decrease the frequency of seizures in epileptics. It is given as a single therapy medication or in combination with other drugs.
Topamax® also is prescribed to prevent migraine headaches. The drug has not been shown to cure migraines once they have begun.
The FDA issued a safety communication March 4, 2011, notifying healthcare professionals and patients that babies born to mothers taking Topamax® from the sixth to the 11th week of their pregnancies had a significantly higher risk of being born with cleft lip and/or cleft palate. Together, cleft lip and palate are called oral clefts.
Data Indicates Danger of Topamax®
Data provided by the North American Antiepileptic Drug Pregnancy Registry show that infants exposed to Topamax® during the first trimester of the mother’s pregnancy have an increased risk of cleft clip and cleft palate.
Oral clefts occurred in 1.4 percent of babies born to mothers taking Topamax®. This compares to a prevalence of 0.38 to 0.55 percent of infants born to epileptic mothers taking other anti-seizure medicines. And, 0.07 percent of babies born to mothers who were not epileptic and did not take antiepileptic medication were born with oral clefts.
The U.S. data were supported by the United Kingdom Epilepsy and Pregnancy register, which show a similarly increased occurrence of oral clefts — 3.2 percent among infants exposed to Topamax®. This is a 16-fold increase in risk compared to the normal population.
The FDA cautioned “the benefits and the risks of topiramate should be carefully weighed when prescribing this drug for women of childbearing age, particularly when topiramate is considered for a condition not usually associated with permanent injury or death.”
Formation of Oral Clefts
The first trimester of pregnancy is when a fetus’ lips and palate form. Until its sixth week when the structures begin to come together, the fetus’ lips and palate are cleft or split into right and left sections of the face. They complete the fusion process about the 12th week of pregnancy. Environmental causes, including exposure to medication such as Topamax®, interfere with this fusion.
Because of the clarity of the data, the FDA changed the pregnancy category of Topamax® from Category C to Category D. Category C means medication has been shown to cause deformities in laboratory animals. Category D indicates the drug has been shown to be toxic in human fetuses.
Contact a Topamax® Birth Defect Lawyer
If you or a loved one has had a baby born with cleft lip or palate or both and the pregnant mother was taking Topamax®, you should contact a Topamax® Birth Defect Attorney. This personal injury lawyer can help you be compensated for the pain, suffering, and expense of having a baby born with an oral cleft.
Contact us to schedule a free evaluation of your case.
