Zofran is a drug approved by the U.S. Federal Drug Administration (FDA) as safe and effective to treat to treat nausea and vomiting in cancer patients undergoing chemotherapy or radiation therapy. It is not approved by the FDA for treatment of morning sickness in pregnant women. However, even though not FDA-approved, Zofran was prescribed to many pregnant women to treat nausea and vomiting and symptoms of morning sickness during pregnancy.
Now, recent studies have linked Zofran to a two-fold increased risk of heart birth defects and cleft palate birth defects in new born babies. Reports have also linked Zofran use to other birth defects such as skeletal and skull malformations and restricted growth, and extremely low birth weights.
We Will Tell You If You Have a Claim and Help You Pursue Compensation Without Any Cost to You
Borri Law Offices is accepting Zofran birth defect cases in all 50 states. If you used Zofran during pregnancy and your child was born with a birth defect, you and your child may be entitled to substantial compensation.
We are offering free consultations. Call us or submit the contact form on the bottom of the page, to speak to a lawyer about your case.
Why Was Zofran Prescribed to Pregnant Women?
The FDA did not approve Zofran for treatment of pregnant women for morning sickness. And, it is illegal for the manufacturer of a drug to encourage doctors to prescribe a drug for a use that is not approved by the FDA. Thus, GlaxoSmithKline, the manufacturer of Zofran, was prohibited from promoting the sale of Zofran for use by pregnant women.
However, doctors can legally prescribe drugs to patients for unapproved uses, as long as the doctor explains the risks and benefits of the drug to the patient and believes the treatment is appropriate. Doctors rely on the package label prepared by the manufacturer to learn about the risks of drugs they prescribe.
Manufacturers and salesmen of pharmaceutical drugs have a profit motive to sell as much of a drug as they can, even if it means encouraging doctors to prescribe the drug for uses which the FDA has not found it to be safe or effective. In 2012, the GlaxoSmithKline paid $1 billions to settle claims by the United States Government that it illegally marketed Zofran (and other drugs) to doctors for treatment of morning sickness in pregnant women. Thus, the federal government beleived there was substantial evidence that GlaxoSmithKline illegally marketed Zofan for treatment of morning sickness
Zofran Linked to Heart Birth Defects and Cleft Palate Birth Defects
Three recent studies published in 2012, 2013 and 2014 have linked Zofran use to heart and cleft palate birth defects in newborns.
- A study of 600,000 births in Denmark found that woman taking Zofran during the first trimester of pregnancy were up to four (4) times more likely to have children with certain types of congenital heart birth defects. Pasternak, et al., Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes, NEJM (Feb. 28, 2013);
- A study of 900,000 births in Denmark found that woman taking Zofran during the first trimester of pregnancy were up to two (2) to four (4) times more likely to have children with certain types of congenital heart birth defects. Andersen, et al., Ondansetron Use in Early Pregnancy and Risk of Congenital Malformations – A Register-Based Nationwide Control Study, presented at the International Society of Pharmaco-epidemiology, Montreal, Canada (2013);
- A study of 1.5 Million Swedish births found up to a two-fold increased risk of certain heart defects in infants of mother that took Zofran during pregnancy. Danielsson, et al., Ondansetron During Pregnancy and Congenital Malformations in the Infant (Oct. 31, 2014)
Reports Link Zofran to Other Birth Defects
Canadian doctors treating mothers who took Zofran during pregnancy in 2012, reported serious birth defects and side effects in 20 babies, including:
- Infant deaths
- Heart defects
- Kidney malformations
- A musculoskeletal malformation
- One baby with a mouth deformity, jaundice, a heart murmer, and two heart defects including a hole in the baby’s heart
- Fetal growth restriction (babies born weighing as little as 4 and ½ pounds)
Pregnant Women Not Warned of Risk of Zofran Birth Defects
In spite of studies and reports linking Zofran use by pregnant women to heart, cleft palate and other congenital birth defects in their new born babies, the manufacturer of Zofran has not adequately warning of this risk in is labeling. The label simply says that Zofran was tested on rats and rabbits and did not reveal harm to the baby rates or rabbits and that “There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”
No mention is made of the studies or numerous reports linking Zofran to birth defects. Thus, doctors are left in the dark.
The has been no Zofran recall. The manufacturer of Zofran continues to claim that it is not a defective, and unreasonably dangerous drug.
Is There a Zofran Class Action Lawsuit?
The is no Zofran class action lawsuit. Zofran cases are filed individually on behalf of an injured infant and his or her parents.
No Zofran lawsuits have been settled yet. This is due, in part, to the fact that the public is just learning of the links between Zofran and birth defects and Zofran lawsuits are just starting to be filed.
Do I Have a Zofran Lawsuit?
Borri Law Offices is accepting Zofran birth defect cases. If you or someone you love took Zofran during pregnancy and had a baby with birth defects, you should contact us today. For a free consultation about your case, call us toll-free at 888-767-6565, or fill out the contact form at the bottom of the page and one of our lawyers will contact you.