By Adam W. Pittman on May 26, 2016
Zofran (generic name: ondansetron) is a popular anti-nausea prescription drug, approved by the US Food and Drug Administration (FDA) for treatment of nausea and vomiting in cancer patients after surgery.
The drug is manufactured by GlaxoSmithKline (GSK), a large pharmaceutical company based in the United Kingdom.
While Zofran is only FDA-approved for treatment of nausea and vomiting in postoperative and cancer patients, it is also prescribed as treatment for pregnancy-associated vomiting and nausea, commonly referred to as “morning sickness.”
Birth defects caused by Zofran
Zofran and its generic form Ondansetron have been linked to birth defects caused by the drug’s non-FDA approved, or “off-label,” use to treat morning sickness in pregnant women.
An estimated 70 to 90 percent of pregnant women experience morning sickness, and about 15 percent of all pregnant women experience morning sickness severe enough to warrant medication.
Morning sickness is most common during the first trimester of pregnancy, although it can still occur later down the line. During the first trimester, the developing fetus is at its most vulnerable to damage caused by a harmful drug.
Zofran use during pregnancy has been shown to significantly increase the risk of severe birth defects.
Potential birth defects caused by Zofran (ondansetron) include, but are not necessarily limited to:
- Heart defects, such as atrial or ventricular septal defects (holes in the heart), and heart murmurs
- Cleft lip and cleft palate
- Kidney damage and/or failure
- Organ malformation or malpositioning
- Miscarriage and stillbirth
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Off-label drugs and pregnancy
“Off label” use describes when a medication is prescribed for a condition(s) not approved by the FDA. Most people would assume that when their doctor prescribes them a drug, that medication has been FDA-approved for the specific condition they have.
However, off-label prescriptions are actually a common practice. About one in five prescriptions written in the United States are off-label, according to a 2006 study by researchers at Dartmouth Medical School.
Ethical considerations prevent most drugs from being tested in pregnant patients before approval. As a result, few drugs are expressly approved for use during pregnancy, and the effects of most drugs on fetal development as well as the risk of birth defects are poorly understood. This also means that the proportion of drugs prescribed off-label to pregnant women is particularly high.
One in four pregnant women in America prescribed Zofran or Ondansetron
In an editorial published in the December 2014 issue of the American Journal of Obstetrics and Gynecology, Dr. Gideon Koren reports:
97.7 percent of prescriptions for the treatment of nausea and vomiting [aka morning sickness] in the United States are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the Food and Drug Administration.
Koren highlights the steady increase in ondansetron prescriptions for treatment of morning sickness from 50,000 per month in 2008 to 110,000 per month in 2013. Assuming this trend has since held steady, this means that roughly 1 million pregnant women out of 4 million total pregnancies per year in the United States are exposed to Zofran or its generic, ondansetron.
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2012 GSK settlement
In 2012, GlaxoSmithKline (GSK) pled guilty on criminal and civil charges brought against the company by the Department of Justice for failure to report safety data and unlawful promotion of a number of its drugs, including Zofran. GSK ended up paying 3 Billion to resolve charges – the largest pharmaceutical settlement in U.S. history.
GSK promoted Zofran for non-approved use for treatment of morning sickness and also paid kickbacks to physicians for prescribing the drug.
This 2012 settlement does not clear GSK of its liability for damages or injuries that may have been caused by Zofran.
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We want to help
The attorneys at Cory Watson have represented families harmed by the negligence and wrongful conduct of others for more than thirty years, and our lawyers are currently representing women and children harmed by Zofran and other drugs.
If you or a loved one were injured by Zofran or another prescription drug, call today for a free consultation at this number: 877-686-8992