In 1991, Zofran was recognized by the Food and Drug Administration (FDA) for use by cancer patients going through chemotherapy and radiation therapy as well as post-operative patients, experiencing nausea and vomiting (NVM). However, in September of 2011 the FDA issued out a statement stating an investigation was underway for Zofran, brand name Ondansetron. The statement cited a worrying link between Zofran and heart defects. These concerns further moved into the none approved uses of Zofran, where the makers of Zofran GlaxoSmithKline (GSK), allowed it to be used as an anti-nausea medication for pregnant women experiencing severe nausea and vomiting (NVM).
Beyond the FDA’s concerns about Zofran possibly causing heart defects, medical communities around the world have tested Zofran’s effects on pregnant women using it for NVM to verify if the drug should be a concern to the health of the developing baby. Majority of these studies have come back with astounding data that has linked the drug to a baby being born with birth defects such as, cleft palate or cleft lip and congenital heart defects. For more information about these studies visit this page here. As it happens, many families have come forward stating that Zofran caused their child to be born with some of the recognized defects and have since filed lawsuits against GSK for false advertisement of their drug as a ‘safe’ drug to be used by pregnant women.
Missouri: Children Born With Abnormalities Data
The latest number of people living in Missouri is recorded as 6,063,589. From that number, the principal cities were:
- Kansas City- 467,007 population
- St. Louis- 318,416 population
- Springfield- 164,122 population
- Independence- 117,240 population
- Columbia- 115,276 population
The Missouri Department of Health gives an up to date list of birth defects in the state, click here to see the list. Everywhere else in the country, the estimation is that one in 33 births results in a birth defect. Considering Zofran started being used in the US in 1991, it has been recognized as the favorite drug for withstanding NVM. It was so well recognized for this particular use in pregnant women that it had claimed nearly 99 per cent of the market in 2005.
Employing this data, as well as averaged possibility percentages established in the clinical studies undertaken, we believe that nearly 3,340 births in Missouri were affected when the mother used Zofran in the first 12 weeks of pregnancy and ended up having a baby with an abnormality.
Possible Stats Of Orofacial Cleft And CHDs In Missouri
Using the supposed figure of 3,340 possible birth defects in Missouri, we have approximated that 570 are some type of orofacial cleft and 2,770 are congenital heart defects or hole in the heart defects. For Missouri’s five main cities the stats for orofacial cleft and CHDs are:
- Kansas City- 270 infant birth abnormalities (nearly: 45 orofacial cleft and 225 hole in the heart defects)
- St. Louis- 200 infant birth abnormalities (nearly: 30 orofacial cleft and 170 hole in the heart defects)
- Springfield- 130 infant birth abnormalities (nearly: 18 orofacial cleft and 112 hole in the heart defects)
- Independence- 105 infant birth abnormalities (nearly: 10 orofacial cleft and 95 hole in the heart defects)
- Columbia- 104 infant birth abnormalities (nearly: 11 orofacial cleft and 93 hole in the heart defects)
What Have Been The Known Adverse Effects Of Using Zofran?
Regardless of the fact that there have been a number of clinical studies undertaken by the medical community, GSK, is not in agreement that their drug, Zofran, has adverse effects that lead to a baby being born with birth abnormalities. Nonetheless, lawsuits that have been brought to court have seen litigants state that Zofran induced some of the following birth defects:
- Hole in the heart
- Renal malformations
- Webbed toes
- Low set ears
- Facial dysmorphia
- Cleft palate
- Club foot
A specific study conducted by the CDC and Sloan Epidemiology found that pregnant women who took Zofran in the early pregnancy stages, doubled the potential of giving birth to a baby born with a cleft palate. For more about this study visit this page here.
Missouri Parents Ready To File A Suit
A number of law firms fund this website, ZofranLegal.com, as a tool to be used for the Zofran suit. Despite the fact that our advocates are not certified to practice law in Missouri, we are certified to practice law in Delaware where we hold offices as well. Delaware is a central state as that is where GSK has its main offices. Being in Delaware means we are fully authorized to stand for your family’s legal rights if a case is filed in that state. Click here for our office details.
Each case that comes our way is individually analyzed in order to come up with the best possible filing scenario. We may suggest that your case be filed in Delaware with our legal team representing you in court, or at a different location, or we may deem it suitable to file your particular case in Missouri utilizing our network of local legal counsel.
Please contact us as soon as possible and we will go over your case with you as well as answer any questions you may have. Our Zofran team is here to speak with you at any time of the day. Meet the team here.