Zofran (Ondansetron) and Cleft Palate

Our drug safety law firm, is investigating claims involving a drug used to treat nausea and vomiting during pregnancy, Zofran (ondansetron). Studies have shown that Zofran (ondansetron) may increase the risk of certain birth defects including cleft palate. Cleft palate occurs when a baby’s mouth does not form properly during pregnancy.

According to a 2012 medical study entitled, “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects”, a two-fold increased risk of cleft palate associated with Zofran (ondansetron) was detected in infants whose mothers took Zofran (ondansetron) for nausea and vomiting during the first trimester of pregnancy (odds ratio 2.37 [95% CI 1.28 to 4.76]).

In evaluating these cases here’s what we look for:

  1. Confirmation that that the child has a cleft palate
  2. Proof that the child’s mother had nausea and vomiting during pregnancy
  3. Proof that the mother used Zofran (ondansetron) during the first trimester of the pregnancy

The next step of our analysis is to rule out other potential causes of your child’s cleft palate. Unless we’re able to do that, we cannot prove that Zofran (ondansetron) caused your child’s condition.

Other potential causes include:

  • a family history of cleft palate (in siblings, parents, or other relatives);
  • genetic disorders known to cause cleft palate;
  • smoking during pregnancy;
  • women with diabetes diagnosed before pregnancy;
  • use of other medications during pregnancy.
Fred Pritzker
Attorney Fred Pritzker and his team are helping mothers and babies harmed by Zofran.

Cleft palate may also occur as a result of exposure to viruses or chemicals during pregnancy, or it may be part of another medical condition altogether. For these reasons, we need to obtain as much information as possible to rule out other causes of cleft palate.

If you used Zofran (ondansetron) during the first trimester of your pregnancy and your child has a cleft palate, we would like to talk to you about your potential case. Please call 888-377-8900 or click here for a free consultation about your child’s cleft palate birth defect case.

We are a national law firm and represent clients with product liability claims throughout the U.S. against drug companies.

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Category: Product Liability
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