Information about Zofran.

Zofran Cleft Lip & Cleft Palate

Have you taken Zofran during pregnancy and given birth to a child with either of these birth defects/side effects?

  • Cleft lip
  • Cleft Palate

Zofran (ondansetron) studies have discovered a link between Zofran use during pregnancy and several different types of birth defects—including malformations of the mouth (cleft lip or cleft palate).

What is a Cleft Lip/Palate?

According to WebMD, “Cleft lip and cleft palate are facial and oral malformations that occur very early in pregnancy, while the baby is developing inside the mother. Clefting results when there is not enough tissue in the mouth or lip area, and the tissue that is available does not join together properly.”

A cleft lip/palate birth defect can range in severity from visible facials marks to serious developmental issues, some of which can cause difficulty eating or breathing.

Differences: Cleft Lip vs. Cleft Palate

Cleft Lip: A physical split or separation of the upper lip that appears as an opening or gap in the skin of the upper lip. Often, the separation extends past the base of the infant’s nose and includes the bones of the jaw or gum.

Cleft Palate: A physical split or opening in the roof of the mouth. A cleft palate can occur in the hard palate (the bony front-portion of the roof of the mouth) and/or the soft palate (the soft back portion of the roof of the mouth).

Since the lip and palate develop separately, it is possible to have both a cleft lip and cleft palate, or each defect can present individually.

How Does a Cleft Lip and/or Cleft Palate Develop?

A cleft lip or cleft palate is the fourth most common birth defect in the U.S.; it affects one in 700 babies annually (WebMD).

The causes of cleft lip and cleft palate birth defects may vary, but include medication taken by the mother during pregnancy. Zofran, a pharmaceutical drug developed to treat nausea in cancer patients, is sometimes prescribed by physicians to treat morning sickness in pregnant women. Several studies have linked Zofran to birth defects, including cleft lip and cleft palate.

U.S Food and Drug Administration (FDA) Zofran Warnings

In 2013, the FDA made an announcement concerning the potential link between Zofran use and birth defects, including cleft lip and cleft palate, citing numerous adverse events reported in the FDA’s internal drug monitoring system, the FDA Adverse Reporting System (FAERS).

Other Zofran-related birth defects reported in the FAERS include musculoskeletal anomaly, jaundice, heart murmurs, and other forms of heart defects.

Read More: Zofran (ondanestron) Studies

What is Zofran?

Zofran (common name ondansetron) is a prescription drug developed to treat symptoms of nausea in cancer patients as a result of surgery, chemotherapy, and/or radiation. However, Zofran has been prescribed by some physicians to treat nausea and vomiting in pregnant women, which may have caused potentially severe birth defects in their children.

File a Lawsuit

If you’ve taken Zofran during pregnancy and your child was born with birth defects including malformations of the mouth (cleft lip or palate), heart defects, skeletal issues or other similar side effects relating to the developmental health of an infant, you may have grounds to file a lawsuit. For information about whether you may have a case, contact the attorneys at Hissey Kientz, LLP by filling out the contact form on this page.

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