February 12, 2015 a Minnesota mom filed a lawsuit against the pharmaceutical GlaxoSmithKline (GSK), alleging that she gave birth to two children with congenital heart defects caused by her taking the pharmaceutical’s drug, Zofran. The mother of two cited that she took Zofran for severe morning sickness for which she remedied with Zofran during her first trimester in both pregnancies. Click here to read more about the filed lawsuit in Minnesota.
What Is Zofran?
Zofran, also referred to as Ondansetron, is a drug made by GlaxoSmithKline in the 80’s with the intention of lessening nausea and vomiting experienced by patients going through chemotherapy and radiation therapy as part of their cancer regimen. How the drug is designed to work is through blocking serotonin in the body. Serotonin, also known as 5-hydroxytryptamine, 5-HT) is a chemical found in our bodies. It’s mainly found in the brain, bowels and blood platelets. Among its many uses, serotonin is responsible for nausea in our bodies, which is why the drug Zofran was designed to block serotonin thereby stopping nausea and vomiting.
The use of this drug makes sense for its intended original purpose, which was to ease nausea and vomiting that comes with chemotherapy and radio therapy. In 1991 the Food and Drug Administration approved Zofran to the limited use of treating nausea and vomiting in chemotherapy, radiation therapy, and surgical patients. The FDA never approved Zofran for the purposes of alleviating morning sickness.
What Is The Link Between Zofran & Birth Defects?
There have been a considerable amount of studies carried out in America, Denmark, China and Sweden, that have linked using Zofran to birth defects such as cleft lip, cleft palate and congenital heart defects. Some of the studies reveal the following results:
- CDC and Sloan Epidemiology Center Report– study associated taking Zofran during the first trimester of pregnancy with double the risk of giving birth to a child with a cleft palate.
- Denmark, Andersen Study- the study concluded that mothers who took Zofran were more likely to have a baby with a congenital heart defect, moms who took Zofran were also 2 to 4 times more likely to birth a baby with a septal cardiac defect.
- Sweden, Danielsson Report- study concluded that mothers who remedied morning sickness by taking Zofran in their first trimester had a 62% increased risk of giving birth to a baby with a cardiovascular defect and had a 200% increased danger of their baby being born with a septal cardiac defect.
For more information about the studies performed linking Zofran to birth defects visit our About Zofran page.
Minnesota Populations & Defect Statistics
Minnesota Health Department reports that there is an estimated 2,000 babies born with a birth defect each year in the state. The Center For Disease Control (CDC) reports a 3%, or 1 out of 33 births in America result in a birth defect. Having a baby born with abnormalities depends on various factors from genetics to medications taken while pregnant.
As of the last census data Minnesota’s population was approximately 5,457,173. Going by this figure we believe there may have been 3,060 total possible birth defects in the state. Below is data of Minnesota’s five major cities by people density.
- Minneapolis- population 400,070
- St. Paul- population 294,873
- Rochester- population 110,742
- Bloomington- population 86,319
- Duluth- population 86,128
As already mentioned, the FDA approved Zofran in 1991 and the drug took off to become a highly prescribed drug in the country.The drug’s popularity saw it gain 99% market share by 2005. Zofran attorneys have calculated the possible figures of births that may have resulted in an abnormality due to the presence of Zofran in the baby’s blood stream, utilizing the information from the epidemiological studies, number of people in a state, as well as cleft lip and palate and congenital heart defects incidences. For Minnesota we believe there were 3,060 births from 1991 when Zofran entered the market, that could have been affected by Zofran usage resulting in any of the aforementioned abnormalities.
Minnesota Cleft Defects & Congenital Heart Defects LinkedTo Zofran
Using the same formula as mentioned above, we calculated possibly 510 orofacial cleft, and 2,550 congenital heart defects that happened due to Zofran being taken in the first trimester. For Minnesota’s largest cities, the statistics are as follows:
- Minneapolis- 240 birth abnormalities (estimated 40 Cleft lip and palate and 200 congenital heart defects)
- St. Paul- 190 birth abnormalities (estimated: 30 Cleft lip and palate and 160 congenital heart defects)
- Rochester- 100 birth abnormalities (estimated 8 Cleft lip and palate and 92 congenital heart defects)
- Bloomington- 90 birth abnormalities (estimated: 8 Cleft lip and palate and 82 congenital heart defects)
- Duluth- 85 birth abnormalities (estimated 10 Cleft lip and palate and 75 congenital heart defects)
What Adverse Effects Are Related To Taking Zofran?
As stated above, there have been studies undertaken by the medical community linking Zofran to various birth defects, but the manufacturers,GSK, are not owning up to the fact that their drug caused the reported abnormalities. However, there have been newly filed lawsuits that have complainants citing that Zofran was the cause of the following birth defects:
- Congenital heart defects
- Kidney malformations
- Syndactyly (webbed toes)
- Low set ears
- Facial dysmorphia
- Cleft palate
These are just some of the reported defects.
How Do I Know If I Have A Zofran Lawsuit?
If you or someone you know was given Zofran for specific use in alleviating morning sickness and the drug was taken within the first trimester time frame of pregnancy, and went on to give birth to a child with one or more of the abnormalities mentioned above,then you may be a Zofran lawsuit candidate. For further information and clarification about how to proceed in this case call our attorneys and receive a free consultation and case evaluation. Our Zofran litigation team is fully qualified to deal with claims such as these. Click here to meet our attorneys.
Who Are The Zofran Minnesota Attorneys?
Information Available For Birth Defects In Minnesota
If you are a Minnesota parent of a child with any of the birth defects mentioned, see the list below which might be useful if you need help regarding your child’s condition.