In 1991, the Food and Drug Administration (FDA) allowed GlaxoSmithKline (GSK) to market their drug as an anti-nausea drug for people suffering from nausea due to their cancer treatments and those who have undergone medical procedures and are experiencing nausea. However, GSK allowed Zofran to be endorsed as a drug that can be taken as an anti-nausea medication for pregnant women experiencing severe symptoms of morning sickness.The FDA never gave the go ahead for Zofran to be promoted for such uses in pregnant women.
Zofran Studies Correlate The Drug With Deformities
There have been various studies that have been conducted from all over the world that found Zofran has adverse effects on an unborn child: Here are some of the studies and result summaries that have been concluded:
- Pasternak Study: it was discovered that moms to be who used Zofran in the early stages of pregnancy were at risk of exposing their unborn baby to be born with ventricular septal defect by 41%.
- Danielsson Study: this study deduced that the presence of Zofran in utero doubled the potential of a baby being born with a hole in the heart and further spiked the chances of another cardiovascular defect occurring by 62%.
- Andersen Study: this study finalized that Zofran increased the potential of a septal cardiac abnormality by 2 to 4 times as well as a 30% rise of deformities.
- CDC and Sloan Epidemiology Center Report: discovered that Zofran doubled the risk of a baby being born with a cleft palate.
To read more about these studies visit this page. Further to these findings there have been lawsuits that have since been filed with litigants stating that Zofran caused some of the birth defects that were found in the studies.
South Carolina: Infant Birth Defect Data
The South Carolina Department of Health and Environmental Control reports that there are approximately 1,800 infants born with a birth defect in SC each year which is 3% or 1 out of every 33 births. There is a SC Birth Defects Program that gathers information on all babies born with birth defects in SC. The reasons that birth irregularities occur varies from gene mutations to medical negligence, even medication that a mother took while pregnant. South Carolina’s most up to date population data is 4,832,482. The principal South Carolina cities from this number are:
- Columbia- 133,358 population
- Charleston- 127,999 population
- North Charleston- 104,054 population
- Mount Pleasant- 74,885 population
- Rock Hill-69,103 population
Utilizing the information that has been recorded above as well as averaged risk ratios pinpointed in the various comparative medical studies undertaken, we evaluate that almost 2,765 newborns that were born in South Carolina were affected by the presence of Zofran in their developmental stages and ended up being born with defects.
Probable Figures Of Orofacial Cleft & Congenital Heart Abnormalities In South Carolina
From the estimation above of 2,765 total probable birth abnormalities, we have further calculated that 453 are some kind of orofacial cleft and 2,312 are congenital heart defects or hole in the heart. We also, appropriated South Carolina’s five principal cities to discover probable defect cases there. The break down is as follows:
- Columbia- approx. total birth defects: 115, approx. orofacial cleft: 15, approx. hole in the heart defects: 100
- Charleston- approx. total birth defects: 110, approx. orofacial cleft: 12, approx. hole in the heart defects: 98
- North Charleston- approx. total birth defects: 99, approx. orofacial cleft: 10, approx. hole in the heart defects: 89
- Mount Pleasant- approx. total birth defects: 85, approx. orofacial cleft: 7, approx. hole in the heart defects: 78
- Rock Hill- approx. total birth defects: 82, approx. orofacial cleft: 6, approx. hole in the heart defects: 76
Documented Zofran Birth Irregularities And Adverse Effects
We have already made mention of the various medical research studies performed and the results that have been associated with taking Zofran. Despite this evidence GSK does not acknowledge these studies and is not taking responsibility of the effects Zofran has on an unborn child. Below are some of the birth irregularities that have been confirmed through filed lawsuits:
- Atrial Septal Defect
- Facial Dysmorphia
- Low Set Ears
- Ventricular Septal Defect
- Heart Murmur
- Renal Dysfunctions
- Cleft Palate
- Bicuspid aortic stenosis
- Supraventricular tachycardia
- Club Foot
How Do I Know If I Have An Imminent Lawsuit?
If Zofran was administered to a pregnant woman experiencing severe symptoms of morning sickness in the first three months of pregnancy, and subsequently gave birth to a child with one of the birth defects mentioned in this article then please call us as you may have an imminent Zofran case to file. Call our Zofran advocates as soon as you can for a no cost consultation.
Also, if you need more details about your case or are not sure if you can file a case due to the nature of the birth defects your child incurred, please call us for clarification as we are looking further into other birth abnormalities that may be related to Zofran and we can take it from there.
Who Are The South Carolina Zofran Attorneys?
When you file a lawsuit your case will be handled by the lawyers at Janet, Jenner & Suggs. This legal team is well equipped and has experience representing medical cases in South Carolina. Get in touch with us if you need to speak to us about your case, we are here to assist you and get the process started.