Fatalities Related to Zofran
Wrongful death occurs when someone dies because of the negligence of another party. Recent research has linked serious birth defects, some resulting in infant death, to Zofran, an anti-nausea drug prescribed off-label (not approved for that purpose) to pregnant women for morning sickness. GlaxoSmithKline, manufacturer of Zofran, should be held accountable for promoting and marketing this dangerous drug without first ensuring its safety, or warning patients of the dangers.
If you have lost a child because of birth defects caused by Zofran, speak with a knowledgeable Zofran attorney as soon as possible by calling (800) 533-3555. Our compassionate legal team at Farah & Farah knows how painful it can be to lose someone you love because of someone else’s negligence. We have devoted our practice to fighting large pharmaceutical companies on behalf of our clients, who have been harmed by dangerous drugs and devices. You can have confidence that we will aggressively pursue justice and compensation for you and your family.
Serious Birth Defects Linked to Zofran
Several recent studies have linked the use of Zofran in the first trimester of pregnancy (when morning sickness typically occurs) to a number of birth defects. Some birth defects linked to Zofran, such as cleft palate and cleft lip, are not typically life-threatening, although they do require repeated surgeries. Sadly, other birth defects associated with this drug are more serious and can result in wrongful death:
- Heart Birth Defects: Danish researchers conducted a study, known as the Anderson Study, on ondansetron (Zofran) use in early pregnancy and the risk of congenital malformations. This study, presented in August 2013, found increased prevalence of major congenital heart defects in children of women who used Zofran in the first trimester of pregnancy. These “hole-in-the-heart” birth defects linked to Zofran often require surgery and can be serious and life-threatening in many cases.
- Kidney Birth Defects: A study published by the National Center for Biotechnology Information (NCBI) in December 2013 found a 20% increase in the risk of birth defects generally when Zofran is used during the first trimester of pregnancy, an increased risk of stillbirth, and a six-fold increase in the risk of kidney defects specifically (although the kidney defect findings were based on a small number of cases.) According to the National Institutes of Health (NIH), many children with kidney birth defects can lead normal lives. However, children with renal agenesis (born with only one kidney) and renal dysplasia (born with both kidneys, one not functioning) have increased risk of kidney disease, which can be life threatening.
Studies Linking Zofran to Birth Defects
In a study published by Motherisk and known as the “Anderson Study,” researchers found a significant increase in the incidence of congenital heart defects in infants whose mothers had filled a prescription for Zofran during the first trimester of pregnancy. This study included all women who gave birth in Denmark between 1997 and 2010. Of the 903,207 births that occurred during that period, researchers identified 1,368 women who took Zofran in early pregnancy, of which 61 gave birth to babies with congenital defects. A study conducted in Western Australia included all births from 2002 through 2005. Researchers compared births of all women who were dispensed Zofran to the births of all women who were not during the same time period. This study found a 20% increased risk of major birth defects and a significantly increased risk of obstructive kidney birth defects when Zofran was taken during the first trimester of pregnancy.
The National Institutes of Health (NIH) published a Canadian Family Physician study conducted to determine whether ondansetron (Zofran) is safe for use during pregnancy. As stated in this publication, a large control study recently conducted by the Centers for Disease Control and Prevention (CDC) and the Slone Epidemiology Center in Boston, MA linked a twofold increased risk of cleft palate birth defects for babies of mothers who took Zofran in the early stages of pregnancy. Researchers concluded that other anti-nausea drugs with better safety records should be used to treat nausea and vomiting in pregnant women.
Legal Recourse for Wrongful Death Caused by Zofran
Although research has shown that Zofran is not safe for use during pregnancy, some doctors continue to prescribe the drug to pregnant women. These women naturally believe that they can trust the advice of their own physicians. The families of babies who are born with and die from birth defects caused by this dangerous drug have to live with the tragic loss of a child, and shouldn’t have to suffer in silence.
If your family has lost a child in a wrongful death caused by Zofran, contact Farah & Farah as soon as possible. We can discuss the details of your case in a free consultation and advise you of your options under the law. Our firm is currently accepting Zofran birth defect cases nationwide. Rest assured that our tenacious pharmaceutical litigation lawyers will provide the dedicated advocacy and professional representation you need.