Zofran Use Tied to Cleft Lip, Cleft Palate Birth Defects

San Diego, CA, July 23, 2015 (Newswire.com) - ​The popular anti-nausea medication, Zofran (ondansetron), belongs to a class of drugs known as serotonin 5-HT3 receptor antagonists, and is commonly prescribed to combat nausea and vomiting in patients undergoing surgery or chemotherapy treatment. However, Zofran is also sometimes prescribed off-label to pregnant women, as a treatment for a severe form of morning sickness called hyperemesis gravidarum. For the roughly one million women who take Zofran or its generic counterpart, ondansetron, it’s important to know that Zofran use during pregnancy may put an unborn baby at risk for severe birth defects, including cleft lip and cleft palate. If you took the anti-nausea drug Zofran while pregnant, and your baby was born with an oral cleft birth defect, consult a skilled Zofran attorney today to explore your possible compensation options.

What are Cleft Lip and Cleft Palate?

Cleft lip and cleft palate are facial and oral malformations characterized by an opening in the lip or roof of the mouth that occurs when there isn’t enough tissue in the mouth area, and the tissue that is present fails to join together properly. Oral clefts like cleft lip and cleft palate occur during the early stages of pregnancy, when the baby is developing inside the mother’s womb and is most susceptible to harm from potentially dangerous medications. Babies born with a cleft lip have a split or separation in the upper lip that appears as a narrow opening or gap that may extend beyond the base of the nose, and includes the bones of the upper gum and/or upper jaw. In babies born with a cleft palate, there is a gap or opening in the roof of the mouth, which can involve the soft palate (the soft back portion of the roof of the mouth) and/or the hard palate (the bony front portion of the roof of the mouth).

Long-Term Effects of Oral Cleft Birth Defects

Cleft lip and cleft palate can affect one or both sides of the baby’s mouth, and can occur separately or together. The oral cleft birth defects result not only in an abnormal appearance in the affected baby’s facial features, but can also interfere with the proper functioning of the mouth and palate, possibly resulting in frequent ear infections and problems with feeding, hearing and speech. In many cases, babies born with cleft lip or palate require surgery to repair the malformation, typically during the first year of the baby’s life. Some affected babies may require long-term speech therapy and ongoing dental care to address the consequences associated with the facial birth defects.

Studies Linking Zofran to Cleft Lip, Cleft Palate

According to national statistics, approximately one in 700 babies is born with a cleft lip, with or without a cleft palate, in the United States every year. However, studies have shown that babies exposed to the morning sickness drug Zofran during pregnancy may have a significantly higher risk of being born with an oral cleft birth defect. According to a study published in the medical journal Birth Defects Research in November 2011, women who become pregnant while taking Zofran may face a 2.4-times higher risk of giving birth to a baby with a cleft palate malformation. The same results were reported in a January 2012 study based on data from 9,000 pregnant women who participated in the National Birth Defects Prevention Study.

Lawsuits Filed Over Cleft Lip or Palate from Zofran

As former Zofran users across the country become aware of the potential for the controversial anti-nausea medication to cause severe birth defects in babies, a growing number of women are filing Zofran birth defect lawsuits against GlaxoSmithKline, on behalf of children born with congenital malformations after being exposed to the morning sickness drug in utero. For example, in April 2015 and May 2015, the parents of two children born with oral cleft birth defects after being exposed to Zofran during pregnancy filed a claim accusing GSK of failing to provide consumers with adequate warnings about the pregnancy risks associated with Zofran treatment. If you believe your child has been harmed by birth defects from Zofran, contact a reputable Zofran lawyer today for legal help. Learn more about Zofran birth defect lawsuits at http://drug-lawsuits.com/zofran/

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