Zofran Birth Defect Lawsuits
Zofran, an anti-nausea drug that is being used “off-label” for morning sickness, has been linked to a 30% increased risk of birth defects and a doubled risk of heart malformations, and cleft palate, according to several recent studies. The Kagan Law Firm is currently investigating cases of the above birth defects in the children of women who were prescribed the drug Zofran as an anti-nausea medication during their pregnancy.
What Is Zofran?
Zofran (ondansetron) is a drug approved by the FDA to treat nausea and vomiting in chemotherapy and surgery patients. It is not approved for use in pregnant women but has gained an increasingly widespread market share as an “off label” prescription for expectant mothers. Currently, there is no law or regulation stopping doctors from prescribing drugs off-label.
How Does Zofran Work?
Zofran is a 5-HT3 antagonist that primarily acts on the nervous system. The drug works by blocking serotonin and increasing gastric emptying, which in turn helps reduce nausea and vomiting. While 70-85% of pregnant women are estimated to be effected by morning sickness during weeks 6-12 of pregnancy, Zofran is not approved for use during pregnancy.
The FDA has classified Zofran as a “Pregnancy Category B” medication, which means that studies on animals have not found evidence of risk, but are unclear if the drug is safe.
Zofran tablets are prescribed in 4 mg and 8 mg dosages. They may be identified as follows:
- ZOFRAN Tablets, 4 mg, are white, oval, film-coated tablets engraved with “Zofran” on one side and “4” on the other in bottles of 30 tablets.
- ZOFRAN Tablets, 8 mg, are yellow, oval, film-coated tablets engraved with “Zofran” on one side and “8” on the other in bottles of 30 tablets.
- ZOFRAN ODT (Orally Disintegrating Tablets), 4 mg, are white, round and plano-convex tablets engraved with a“Z4” on one side in unit dose packs of 30 tablets.
- ZOFRAN ODT (Orally Disintegrating Tablets), 8 mg, are white, round and plano-convex tablets engraved with a “Z8” on one side in unit dose packs of 30 tablets.
Zofran Pregnancy Study Results
In 2013, a study was conducted and published by the New England Journal of Medicine that concluded Zofran did not increase the risk of birth defects. Six months after this study was published, a separate team of researchers looked at the same database of pregnancy outcomes and found that Zofran had doubled the risk of having a baby with heart defects, leading to a 30% increased risk of birth defects. About 5% of babies exposed to Zofran had birth defects, compared to 3.5% who were not exposed to the drug.
A study conducted in December 2014, by Reproductive Toxicology was published by researchers who found that Zofran doubled the risk of septal heart defects (which are also known as “hole in the heart” defects). Study conclusions were based on data from 1,349 infants whose mothers had taken Zofran early during their pregnancy from 1998-2012.
Additional Birth Defects Linked To Zofran
In June of 2014, an investigation took place by the Toronto Star, which reported 20 cases of Canadian women who had a baby with a birth defect after using Zofran. Some of these birth defects included the following:
- Heart defects
- Kidney Malformations
- Musculoskeletal abnormalities
- Mouth deformity
- Fetal growth restriction
- Fetal death
Contact The Kagan Law Firm Today
The Kagan Law Firm is currently accepting Zofran induced injury cases throughout the country. If you or someone you know has had a baby with a birth defect after taking Zofran during pregnancy, we urge you to contact our office immediately for a free consultation.
Please fill out the form below to contact us, and we will promptly follow up with you. If you would prefer to speak with one of our attorneys immediately, we can also be reached at (239) 466-1161.