Our dangerous drug attorneys are currently working with women and families across the nation to file Zofran birth defect lawsuits after they gave birth to a child with a serious congenital birth defect as a result of using Zofran to treat morning sickness.
Zofran is in the FDA’s “Pregnancy Category B”, which means that the effects of Zofran on human fetal development have not been adequately studied at this time. Most women who use Zofran for morning sickness do so during the first trimester of pregnancy, when morning sickness symptoms are often the most severe. Unfortunately, the first trimester is also when most congenital birth defects are formed.
A study published in December 2015 in Clinical Pharmacology & Therapeutics found that Zofran travels through the placenta more quickly than other drugs and that it can remain in the system of a developing baby long after the drug has been expelled from the mother’s body. Another study conducted in 2006 in Hong Kong found Zofran at higher-than-expected levels in fetal tissue samples, also leading researchers to conclude that Zofran may have a profound effect on fetal development.
In 2012, the journal Birth Defects Research published a study where researchers relied on data about roughly 9,000 women compiled by the National Birth Defects Prevention Study. These researchers determined that use of Zofran during pregnancy can may a woman 2.4 times more likely to give birth to a baby with an oral cleft birth defect.
Oral cleft birth defects such as cleft lip and cleft palate are a result of incomplete development of the roof of a baby’s mouth. This may result in deformations which are solely cosmetic in nature, but a severe cleft lip or cleft palate may make it difficult for a baby to feed and may also affect a baby’s dental structure, nasal cavity, and gums.
When Danish researchers evaluated data from more than 900,000 pregnancies, they concluded that babies exposed to Zofran in the womb are up to two times more likely to be born with a serious congenital heart defect. Heart birth defects linked to Zofran include:
In addition to a heightened risk of oral cleft and heart defects, women who use Zofran during pregnancy are also at a higher risk of having a baby with the following serious birth defects:
In Zofran birth defect lawsuits, multiple mothers who gave birth to children with severe defects have claimed that had they been warned of the severity and likelihood of Zofran birth defects, they would not have used the drug during pregnancy. We have evidence that GlaxoSmithKline knew of the risk of Zofran birth defects as early as the 1980s, but that they willfully hid this information in order to increase their own profits. The company was also found guilty in a federal investigation in 2012 of illegally marketing Zofran for off-label use during pregnancy and for providing kickbacks to doctors who prescribed the drug for morning sickness.
If you believe that you may be entitled to compensation in a Zofran birth defect lawsuit, please contact our attorneys today to schedule a free and informative legal consultation.
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