The nausea and vomiting prevention drug, Zofran, has been linked to several side effects, including such serious injuries as:
- Cleft lip;
- Cleft palate;
- Heart defects.
If you or a loved one took Zofran for morning sickness and your baby was born with a serious birth defect or died, you may be entitled to a cash award and compensation for medical expenses.
For a free confidential consultation, please call 1.800.988.8005 or submit an email inquiry above.
What Is Zofran?
Zofran (ondansetron) is a prescription drug manufactured and marketed by GlaxoSmithKline (GSK). Zofran is FDA approved to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and also in post-surgery patients.
Zofran is a 5-HT3 antagonist that works by blocking serotonin, which helps prevent nausea and vomiting. Zofran was FDA approved in 1991 and a generic version, ondansetron, was introduced in 2006. It can be administered in the form of a tablet, liquid, or injection.
Zofran during Pregnancy
Zofran is not FDA approved to treat morning sickness, but physicians have been prescribing the drug to pregnant women to treat morning sickness nausea and vomiting symptoms.
The FDA classifies Zofran as a Pregnancy Category B medication, which means animal studies have not found evidence of a risk. There have been no adequate and well-controlled studies in pregnant women.
In 2006, a study published in the International Journal of Obstetrics and Gynecology found that Zofran crosses the human placenta, in significant concentrations.
Zofran Studies: Pregnancy & Birth Defects
In June 2014, the Toronto Star published an article on its findings after a detailed analysis of the FDA’s public side-effect report database on Canadian women who had taken Zofran during pregnancy.
In reviewing the FDA database for 2012, The Star found 20 reported incidents of child birth defects in women who were prescribed and ingested Zofran “off-label”. These defects included:
- Heart defects, including ‘atrial septal defect’, otherwise known as a hole in the heart;
- Musculoskeletal anomaly;
- Fetal growth restriction, including babies weighing as little as 4.5 pounds;
- Mouth deformities;
- Heart murmurs;
- Kidney malformations;
- Infant deaths.
Zofran Heart Defects
In December 2014, a study published in the medical journal Reproductive Toxicology examined data in the Swedish Medical Birth Register. Researchers identified 1,349 infants exposed to Zofran early in pregnancy between 1998 and 2012, finding that there is a statistically significant risk for cardiovascular defects. Mothers prescribed Zofran early in pregnancy were 1.62 times more likely of giving birth to a child with a cardiovascular defect, and 2 times more likely to have a cardiac septum defect.
In August 2013, a group of researchers reviewed the Danish Medical Birth Registry with nearly 900,000 pregnancies from 1997-2010. The study concluded that children exposed to Zofran were 1.3 times more likely to have a major malformation, and 2 times more likely to have a major congenital heart defect.
In December 2013, BioMed Research International published a study, which Australian researchers found a 20% increased risk of a major birth defect. Zofran was also linked to a 6-fold increased risk of obstructive defects in the renal pelvis and ureter. Obstructive defects can result in hydronephrosis, which can cause kidney failure.
Zofran and Cleft Palate
In November 2011, a study was published by the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology. Researchers found that children exposed to Zofran prenatally are 2.37 times more likely to be born with cleft palate.
GlaxoSmithKline Pays $3 Billion for Illegal Off-Label Marketing
In 2012, the U.S. Department of Justice reached a $3 billion settlement with GlaxoSmithKline after the government alleged the company promoted the off-label uses of several drugs, including Zofran. Court documents also alleged the company gave doctors kickbacks to prescribe the drug for morning sickness.
How We Can Help
Levy Konigsberg LLP is currently accepting Zofran injury cases in all 50 states. If you or a loved one took Zofran for morning sickness and your baby was born with a serious birth defect or died, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation, please call 1.800.988.8005 or submit an email inquiry above.