The Zofran lawyers at Pintas & Mullins Law Firm are currently accepting cases of birth defects in children whose mothers took this anti-nausea drug during pregnancy. Many patients are surprised and angry to learn that Zofran has never been approved to treat morning sickness; it is only FDA-approved to treat nausea and vomiting in patients undergoing chemotherapy, radiotherapy or after surgery.
Zofran and Zuplenz work by blocking serotonin in the area of the brain that triggers nausea and vomiting. Zofran was the first drug of its kind to be approved, in 1991, and is manufactured by Big Pharma giant GlaxoSmithKline (GSK). Nausea from chemotherapy and other treatments is not a large market, so GSK quickly recognized it needed to expand its target patient to those outside cancer centers. Who else suffers from consistent and sometimes debilitating nausea? Pregnant women.
An estimated 80% of pregnant women experience nausea during their pregnancy. “Morning sickness” in its most severe form, hyperemesis gravidarum, can be extremely dangerous to mother and child and result in severe malnutrition and dehydration. This severe form of morning sickness only occurs in 1 to 2% of pregnancies.
GSK recognized the potential market for its anti-nausea drug and started marketing Zofran heavily to obstetricians and expectant mothers. The campaign was massively successful; about one million pregnant women in the U.S. take a version of Zofran every year.
Over the last few years, several studies have been published linking Zofran to severe birth defects. The first, in 2011, found children exposed to Zofran in the womb were two-times more likely to have a cleft palate compared to children not exposed to the drug.
Then, in 2013, a Danish study of more than 900,000 women found that babies exposed to Zofran had a two-fold increased risk of cardiac malfunctions and a 30% increased risk of congenital malformations.
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During this time, in the summer of 2012, GSK plead guilty and agreed to pay $3 billion to resolve fraud allegations over several drugs, including Zofran. GSK was accused of illegally promoting certain drugs, failing to report safety data, and false pricing. It is the largest payment to the Department of Justice ever by a drug company, and the combination of this and the scientific studies finally revealed that Zofran was in fact not safe for women to be taking while pregnant.
Largest Healthcare Fraud Settlement in U.S. History
The $3 billion settlement over fraud allegations concerned the drugs Avandia, Paxil, Wellbutrin, and Zofran. GSK plead guilty to promoting Zofran for morning sickness, and paying doctors to prescribe it for this use.
Even more troubling are GSK’s own internal documents which prove that the company knew Zofran could pose a risk to infants since the 1980s. According to court documents, GSK conducted animal studies in the 1980s on Zofran. The animals exposed to the drug had premature births, intrauterine fetal deaths, and incomplete bone growth. Some animals showed signs of developmental retardation and congenital heart defects as well.
Anything a mother consumes can cross the placental barrier and be excreted in breast milk. Fetal tissue test have found more than 40% Zofran concentration in the mother’s blood. Infants exposed to Zofran in the womb show an increased risk of:
- Cleft lip or palate
- Skull deformities
- Physical deformities
- Heart defects
- Hearing loss
- Abnormal blood pressure
- Club foot
- Webbed toes
- Vision, stomach, or mental problems
Women whose children suffered severe birth defects after taking Zofran during pregnancy have begun filing lawsuits against GSK. You and your child may be entitled to significant compensation through a lawsuit against GSK.