On March 4, 2011 the FDA warned that new data showed that infants born to women treated with topiramate (Topamax and generic products) during pregnancy have an increased risk for developing cleft lip or cleft palate (oral clefts).
Topamax, generic name, topiramate, is in a class of drugs known as anticonvulsants. It is used along with other drugs to treat people with epilepsy and to to control seizures in people who have Lennox-Gastaut syndrome. It is also used to prevent migrane headaches but not to treat pain. On March 4, 2011 the FDA issued new warnings citing data that showed an increased risk of cleft lip or cleft palate in infants born to women treated with Topamax (topiramate) during pregnancy. Because of new human data that showed an increased risk for oral clefts, the FDA ordered that topiramate be placed in Pregnancy Category D. Category "D" is used when "there is positive evidence of human fetal risk".
The scientific data shows that children born to mothers who took Topamax in the first trimester of pregnancy are twenty-one (21) times more likely to be born with a cleft lip or cleft palate than those unexposed. It is estimated that the incidence of cleft lip in the unexposed white population is approximately 1 in 1000 live births. Asians have a higher incidence while while the incidence in the black population is approximately half as prevalent. Based upon the relavant data summarized by the FDA "[t]he relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 21.3 as compared to the risk in a background population of untreated women (95% Confidence Interval:7.9 – 57.1). These results go well beyond the doubling of the risk generally required for a general causation opinion.
The FDA has stated that from January 2007 through December 2010, approximately 32.3 million topiramate prescriptions were dispensed. It is estimated that 4.3 million patients filled topiramate prescriptions in the United States during that period. In 2008, the major market sales of anticonvulsants reached $13.6 billion, making it one of the largest therapeutic drug classes in the Pharmaceutical sector.
If you took Topamax or generic topirate during your pregnancy and had a child born with a cleft lip or cleft palate, your child may be entitled to significant compensation. Our attorneys have successfully recovered millions of dollars on behalf of children who were born with birth defects as a result of their innocent exposure to prescription drugs during pregnancy.
If you or someone you know had a child who was born with a cleft lip or cleft palate, and the child was exposed to Topamax (topirate) during pregnancy, they may be entitled to significant compensation. Contact us today to learn whether your child can be compensated.
Make sure to contact our experienced, compassionate, and knowledgeable DrugSettlement.com birth defects lawyers by using our contact form or call the number above.
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