Zofran: An Off-Label Anti-Nausea Drug
Zofran is a drug that was allowed to be used by the Food and Drug Administration in 1991, by cancer and post operative patients suffering from nausea and vomiting induced by their treatments. The makers of the drug GlaxoSmithKline, further went on to allow the drug to be used for the same anti-nausea purposes in pregnant women suffering from intense nausea and vomiting. What GSK was doing is called off-label drug marketing.
Off-label marketing is not uncommon, and it is believed that more than one in five outpatient scripts written in the United States is for off-label purposes. Off-label means the medication being prescribed is being used for purposes not originally approved by the FDA. Unfortunately, some of these off-label drugs have not been scientifically proven to be useful for what they are being promoted to remedy. A Dartmouth Medical School 2006 study found that as much as 61% to 84% of off-label drugs had very little scientific backup. This is the case with Zofran, its off-label usage as an anti-nausea medication for pregnant women had little scientific support as a safe drug for use while pregnant. Needless to say, there have been many lawsuits that have been filed all over the United States due to birth defects that have been associated with an unknowing expectant mom taking Zofran for morning sickness and instead exposing her child to severe birth abnormalities.
Colorado: Newborn Birth Abnormalities Figures
The Centers for Disease Control & Prevention (CDC) accounts that about 3,250 (5%) of all births in Colorado each year have a major birth defect. Nationally, CDC accounts for one in every 33 newborns being born with some type of abnormality. From the time Zofran was accessible to the American market in 1991, it became the go-to drug to stave off morning sickness while pregnant. So great was the response to Zofran that it held nearly 99% of the market in 2005. Colorado’s latest population number is estimated to be 5,355,866.
Making use of this information, as well as averaged prospect ratios classified in clinical studies, we believe that there are nearly 3,010 newborn births in Colorado that were affected by the consumption of Zofran in the first 12 weeks causing the baby to be born with an abnormality. To learn more about the studies conducted that have correlated Zofran and birth defects, please go here.
The population figures of Colorado’s five principal cities are:
- Denver- 649,495
- Colorado Springs- 439,886
- Aurora- 345,803
- Fort Collins- 152,061
- Lakewood- 147,214
Likely Cases Of Orofacial Cleft and CHDs In Colorado
Considering Colorado’s population is 5,355,866, we have appropriated this number in order to come up with the likely number of orofacial cleft and congenital heart defects (CHDs) cases that were as a result of taking Zofran. The case estimations are 500 orofacial cleft cases and 2,510 CHDs cases. For Colorado’s five principal cities the cases are:
- Denver- 355 likely birth defects with about 60 orofacial cleft, and 295 CHDs
- Colorado Springs- 260 likely birth defects with about 45 orofacial cleft, and 215 CHDs
- Aurora- 215 likely birth defects with about 35 orofacial cleft, and 180 CHDs
- Fort Collins- 120 likely birth defects with about 13 orofacial cleft, and 107 CHDs
- Lakewood- 119 likely birth defects with about 14 orofacial cleft, and 105 CHDs
What Are The Disclosed Adverse Effects Of Taking Zofran?
Lawsuits that have come our way have seen complainants disclose that Zofran was the agent that led to a child being born with grave birth deformities when the drug was administered in the first 12 weeks of pregnancy. These allegations base their claims on the findings of clinical studies carried out all over the world. The following are some of the disclosed adverse effects of using Zofran while pregnant:
- Heart Murmurs
- Renal Dysfunctions
- Cleft Palate/Lip
- Facial Dysmorphia
- Webbed Toes
- Low set ears
- Cardiac Septum Defects
Regardless of these lawsuits and the claims that the litigants have made about Zofran causing these types of birth abnormalities, among others, GSK refutes that their drug caused such defects.
Colorado Parents Are Making Contact Using ZofranLegal.com
ZofranLegal.com is financed by a few law firms located in different parts of the country. The website is a portal for all news related to the Zofran lawsuit. Although our team is not licensed to practice law in Colorado, we are authorized to practice law in Delaware. We have offices in Delaware that also make it convenient for us to file your case there as well. In addition, GSK has its headquarters in Delaware State.
When you come to us, we carefully evaluate your case and map out the best way to file your lawsuit. One way to file is to have your case filed in Delaware State where we have offices and can represent your family, or we may suggest another fitting venue, or we may recommend that your case be filed right in your home state of Colorado utilizing our trusted network of local counsel.
Please do not hesitate getting in touch with us as soon as possible. Our lawyers are here to speak with you at all hours of the day and night. Meet our Zofran advocates here.