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Drug Zofran Prescribed for Morning Sickness Deemed Dangerous in Pregnant Women

If you have morning sickness and are taking Zofran (ondansetron), especially during the first trimester of pregnancy, please contact your doctor to discuss the risks associated with this drug to determine whether it is right for you.  Taking Zofran can be extremely dangerous to your unborn child and cause serious birth defects including cleft palate and heart defects.  Morning sickness, or nausea and vomiting during pregnancy, occurs in approximately 80-85% of pregnant women. Several medications can be used to alleviate morning sickness, but there is insufficient data on how these drugs connect with birth defects. Some anti-nausea medications, like Bendectin, which were previously believed to be safe for pregnant women, were later removed from the market after birth defects were observed.

Zofran Use During Pregnancy

Some doctors prescribe Zofran (manufactured by GlaxoSmithKline) for nausea and vomiting in pregnant women, even though its safety for use during pregnancy remains unknown. This is largely because there is no FDA-approved drug for this condition. Zofran is not labeled for use to combat nausea and vomiting in pregnancy in either the United States or Canada.  A study published in China has found that the drug is teratogenic (able to cause congenital birth defects) because it is readily able to pass through the placenta in early pregnancy in a concentration that is high enough to cause abnormal fetal development. The Slone Epidemiology Center and the Centers for Disease Control and Prevention found that women exposed to the 5HT3-receptor antagonist Zofran during the first trimester of pregnancy were observed to have a 2.37 times increased risk of having a child born with a cleft palate birth defect.

The U.S. Food and Drug Administration (FDA) has issued an updated warning that it is continuing to evaluate whether taking Zofran while pregnant may cause serious birth defects or complications for the mother. Regardless of this warning, Zofran is still being prescribed to many women who may not be aware of potential side effects.

What is Zofran FDA Approved For?

Zofran was developed to help cancer patients who face nausea as a result of surgery, chemotherapy, and radiation. The FDA has not restricted the sale of Zofran, and doctors may prescribe it as they see fit, regardless of its intended purpose.  This is commonly known as prescribing a drug “off-label”  – something doctors are permitted to do and do all of the time.  Zofran is generally administered via an orally swallowed tablet, at a rate of once or twice per day. The drug helps to block chemicals in the body that cause nausea, and is most commonly prescribed to women facing extreme bouts of nausea and vomiting. Since chemotherapy patients and pregnant women who are already nauseous and vomiting will potentially throw up a tablet, the medication is also available in dissolvable wafers and injections.

What Birth Defects Can Zofran Cause?

Infants born to mothers who took Zofran during pregnancy may be born with malformations of the mouth, including a cleft lip or cleft palate. A cleft palate refers to a split in the roof of the mouth, while a cleft lip includes a gather or split in the mouth area. These disfigurations of the face can range from visible facial marks to massive developmental shortcomings, which can cause difficulty eating or breathing. Although modern surgeries can sometimes correct these birth defects, a child may face a lifetime of scarring or injuries so severe that they cannot be fully corrected. According to a study conducted by the National Center for Biotechnology

Severe birth complications caused by Zofran also include defects in the development of the infant’s heart. An article in Reproductive Toxicology found that the risks for a cardiovascular defect, most notably a cardiac septum defect were increased and statistically significant. This indicates an increased risk that mothers who take Zofran during pregnancy will give birth to a baby with a “hole in the heart,” also known as an atrial septal defect or a ventral septal defect. The article cites a Denmark study showing a 2.0 times increased risk of congenital heart malformation after first trimester exposure to Zofran.

Attorney Claudine Homolash Can Help You

If you or someone you know took Zofran during pregnancy for nausea, and your child was born with birth defects such as a cleft palate or congenital heart defect, you may be entitled to compensation.  Please contact us today or call 1-844-677-4276 for a free legal consultation.

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