In 1991 the Food and Drug Administration (FDA) gave approval of the drug Zofran for commercial use in the United States to patients afflicted with extreme nausea and vomiting due to ongoing chemo and or radiation therapy as well as for post-operative procedures.
However, GlaxoSmithKline, the manufacturers of the drug, started marketing Zofran from 1991 onwards as an “off-label” drug for pregnant women experiencing unbearable morning sickness. Off-Label medication is medication that may not be approved for the specific condition you are suffering from. The term off-label also means the medication is being used in a way that it was not specified for in the FDA’s approved insert (packaging label). This is exactly what happened to Zofran users who were prescribed Zofran for the use of morning sickness and not its original intended use for cancer and post-operative patients.
Subsequently, there has been substantial scientific evidence that has linked Zofran to birth defects in the event that an expectant mom took Zofran in the first twelve weeks of pregnancy. For more about the Zofran scientific research visit our about Zofran page.
Georgia State’s Birth Defect Data
Centers For Disease Control (CDC) informs that for every 33 babies born in America one is said to have a birth defect. A birth defect or abnormality is a serious condition that can change the structure of one or several parts of the baby’s body. A defect can affect any part of the body and can change how the body looks and works. Although common, birth abnormalities can be due to, but not limited to, medical malpractice, or genetic mutations.
2014 the United States Census Bureau pegged Georgia’s population at 10,097,343. Of this number it is estimated that the following are Georgia’s five most populated cities according to population density figures:
- Atlanta- 447,841 population
- Columbus- 202,824 population
- Augusta- 197,350 population
- Savannah- 142,772 population
- Athens- 119,980 population
Since Zofran started being marketed in 1991, it gained popularity that saw it become one of the most prescribed drugs in the country. The drug gained so much popularity that it is understood it had secured 99% market share. By utilizing the birth defect likelihood estimates from conducted clinical researches, population data, and cleft lip/plate and congenital heart defects ratios, we have calculated that there were 5,700 possible Zofran related birth defects in the state of Georgia from the time Zofran was made available for public use.
Zofran Related CHDs & Cleft Deformities In Georgia
Making use of the above estimates, we have determined the Georgia State Zofran associated orofacial cleft and congenital heart defect figures to be 1,400 and 4,300 respectively. Applying the same formula as above we have estimated the Zofran induced birth defects for Georgia’s five major cities. The data are as follows:
- Atlanta- 260 total birth deformities (nearly: 90 orofacial clefts and 170 congenital heart defects)
- Columbus- 145 total birth deformities (nearly: 20 orofacial clefts and 125 congenital heart defects)
- Augusta- 140 total birth deformities (nearly: 20 orofacial clefts and 120 congenital heart defects)
- Savannah- 120 total birth deformities (nearly: 15 orofacial clefts and 105 congenital heart defects)
- Athens- 110 total birth deformities (nearly: 10 orofacial clefts and 100 congenital heart defects)
Adverse Reactions Correlated With Ingesting Zofran
Despite the clinical research studies performed that evidenced Zofran as a birth defect agent, manufacturers GSK -deny that their drug could have have been the cause of such defects. Nonetheless,filed lawsuits against GSK have seen complainants state that the drug caused some of the following abnormalities in their children:
- Atrial septal defect
- Facial dysmorphia
- Heart Murmur
- Low set ears
- Kidney malformations
- Cleft palate
Pursuing A Zofran Litigation
If the information you have been reading rings true to you or someone dear to you, where there was Zofran usage in the early stages of pregnancy that resulted in a baby being born with one or more of the birth abnormalities mentioned above, then you may have a Zofran litigation to pursue.
If there is uncertainty about the link between your child’s defect and Zofran, still contact us. We are in the process of looking into various defects and we can provide you with some valuable information.
Our Zofran attorneys are offering free case evaluations and are accessible to you at any time. Meet our litigation team here.
Georgia Zofran Attorneys
Our Zofran lawyers are fully qualified and licensed to practice law in all of Georgia. If you would like to speak with your Georgia advocate about pursuing a Zofran birth defect case, call us. To find out more about our GA authorized lawyers, click here.