Zofran Linked to Risk of Cleft Palate, Lip Malformations

Use of the morning sickness drug Zofran early in pregnancy may increase the risk that babies will be born with oral cleft birth defects. The lawyers at Saiontz & Kirk, P.A. are reviewing potential cases for children who have suffered facial deformities, such as a cleft palate or cleft lip.

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For many children throughout the United States, these serious problems may have been avoided if adequate warnings had been provided about the risk of cleft lip or cleft palate from Zofran.

Although it appears that GlaxoSmithKline knew or should have known about the potential problems that may result from use of Zofran during the first trimester of pregnancy, information was withheld from women and the medical community.

The lawyers at Saiontz & Kirk, P.A. are pursuing potential Zofran cleft palate and cleft lip lawsuits for families throughout the United States. Claims are also being reviewed for children who may have suffered heart defects from Zofran.

All case are pursued under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire our Zofran birth defect lawyers and we receive no attorney fees or expenses unless a recovery is obtained for your child. Request a free consultation and claim evaluation.

Zofran Pregnancy Link to Cleft Palate, Cleft Lip

Zofran (ondansetron) is commonly used during pregnancy to treat morning sickness or hyperemesis gravidarum (HG). However, that is an “off-label” use that has never been approved by the FDA as safe and effective for pregnant women or unborn babies.

Although Zofran was only intended for use among chemotherapy, radiation treatment and surgical patients experiencing nausea and vomiting, GlaxoSmithKline has illegally marketed and promoted the drug for pregnant women, withholding information about the potential risk that babies may develop a cleft lip or cleft palate from Zofran.

Studies have established that Zofran crosses the placenta, exposing unborn children to the medication at high levels. Early in the development of the fetus, this could cause serious defects and malformations that impact the baby for the rest of their life.

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology examined the Zofran link to oral cleft defects.

Using data from the National Birth Defects Prevention Study (NBDPS), researchers set out to evaluate whether morning sickness or various treatments may be linked to non-cardiac defects, such as clefts.

The findings specifically suggest that use of Zofran for morning sickness may increase the risk that children will experience cleft palate malformations by a ratio of 2.37 to 1. This has also led to concerns within the medical community that there may be link between Zofran and cleft lip defects.

Cleft lip and cleft palate malformations, together referred to as oral clefts, occur early in pregnancy and result in not enough tissue in the mouth or lip for them to merge and form properly. In cleft lip malformations, this manifests as a physical split in the upper lip. In cleft palate malformations it results in a whole or split in the roof of the mouth.

Oral cleft defects can cause problems with talking, eating, and can increase the risk of ear infections and other health problems. They often require corrective surgery to fix.

Zofran Cleft Lip, Palate Lawyers

GlaxoSmithKline knew or should have known that Zofran pregnancy use may cause cleft palate, cleft lip or other birth defects for babies. However, the drug makers chose not to conduct any large-scale studies on the risk of Zofran use during the first trimester of pregnancy.

The failure to study the cleft palate risk with Zofran and lack of any warnings, combined with the illegal “off-label” marketing of the drug over a number of years, have created the false impression that Zofran is pregnancy safe.

Babies born with a cleft palate, cleft lip or other facial malformations may have avoided serious health complications from Zofran if GlaxoSmithKline had not placed their desire for profits before the safety of consumers.

The Zofran class action lawyers at Saiontz & Kirk, P.A. are pursuing claims for children throughout the United States who have suffered problems from the medication, including:

  • Cleft Palate
  • Cleft Lip
  • Heart Defects
  • Other Birth Malformations

To review a potential claim for your child, request a free consultation and claim evaluation to learn what legal options may be available as a result of GlaxoSmithKline’s failure to warn about the risks linked to Zofran use while pregnant.