A baby with cleft lipA cleft lip occurs when the upper lip is split to form a narrow gap that can extend to the base of the nose. This birth defect may also involve the gum and upper jaw bones. Cleft lip occurs in approximately 1 in 700 births. Cleft palate occurs when the roof of the mouth is split by a narrow gap. This birth defect is seen in approximately 1 in 970 births. While cleft lip and cleft palate are relatively common birth defects, the use of Zofran may significantly increase the risk of these birth defects.

Zofran Birth Defects – Cleft Lip and Cleft Palate

The attorneys of the nationwide law firm of Bernstein Liebhard LLP is investigating claims filed on behalf of families whose babies were born with a Zofran oral cleft defects allegedly due to the mother’s use of Zofran during the early stages of pregnancy. Recently, studies have begun to show an increased risk of birth defects in babies born to mothers who used Zofran. If you took Zofran to help treat morning sickness and your baby was born with an oral cleft, you may be entitled to monetary compensation to help you recover medical expenses related to your child’s Zofran birth defect.

When babies are born with an oral cleft defect, they may have trouble feeding or other problems that could impact their growth and development. When this occurs, the baby may have to endure reconstructive surgery to correct the birth defect. Some babies may require multiple reconstructive procedures that begin while they are still very young. If you believe Zofran may have caused your baby’s cleft, our attorneys will fight to hold GlaxoSmithKline accountable for your child’s suffering. To learn more about Zofran cleft palate birth defects, call our office now at 1-844-4-ZOFRAN.

Research Links Zofran to Oral Clefts

Zofran is a medication manufactured by GlaxoSmithKline and approved by the U.S. Food and Drug Administration (FDA) to treat nausea in patients after surgery and patients who are undergoing certain cancer treatments. Zofran is commonly used off-label, by physicians as a treatment for severe nausea and vomiting in pregnant women, even though the drug’s use as a treatment for morning sickness has not been approved by the FDA.

A study published in the journal Birth Defects Research in January 2012, reported that data collected for the National Birth Defects Prevention Study from 9,000 pregnancies indicated that that babies born to mothers who took Zofran during the first trimester of pregnancy were more than twice as likely to be born with an oral cleft as babies born to mothers who did not consume the anti-nausea medication.

That same year, GlaxoSmithKline paid the U.S. Department of Justice $3 billion to settle allegations of illegally marketing Zofran and several other drugs. Included in those allegations was that the company promoted Zofran as a morning sickness drug, though it was not approved as such, and paid physicians kickbacks to prescribe the medication.

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