Zofran is a 5-HT3 receptor antagonist produced by GlaxoSmithKline (GSK), also referred to as Ondasetron. Zofran was designed to affect serotonin levels in the brain. Serotonin is responsible for nausea and vomiting in the body. Upon its approval in 1991, Zofran was certified for use in cancer patients or after surgery patients experiencing nausea and vomiting due to their treatments. However, Zofran makers, allowed the drug to be used as an “off-label” drug to treat nausea and vomiting experienced by women during pregnancy. Zofran was never approved as a safe drug for this type of use in pregnant women.
It is believed that almost 80 percent of pregnant women experience nausea and vomiting during pregnancy and almost one million pregnant women are exposed to Zofran or some generic version of it every year. So, what is so wrong with this popular drug?
The problem with Zofran is that it did not go through extensive testing that would qualify it to be a safe prescription drug for pregnant women. In fact, there have been several epidemiological studies that have linked Zofran to certain birth defects such as cleft palate and congenital heart birth defects, among others, when Zofran was taken in the early stages of pregnancy. To learn more about the scientific association of Zofran and infant birth defects click here to access our about zofran page. To this knowledge, there have been many lawsuits filed against GSK, by parents who have experienced first hand, the unfavorable effects Zofran has on a baby exposed to the drug in utero.
Child Birth Defect Stats in Pennsylvania
The population of Pennsylvania in 2010 was 12,702,379 in accordance to the most recent census data. Of that figure, the most densely populated cities were:
- Philadelphia – 1,526,006 population
- Pittsburgh – 305,704 population
- Allentown – 118,032 population
- Erie – 101,786 population
- Reading – 88,082 population
Based on CDC estimates there is one birth defect for every 32 live births. Zofran was ready for use in the United States following FDA approval in 1991 and has been known as the drug of choice for combating morning sickness among pregnant women, with a close to 99% market share in 2005.
By appropriating this info, as well averaged hazard ratios recognized in various clinical studies under taken, we calculated that generally 6,000 infant births in Pennsylvania that were affected by the usage of Zofran in the early months of pregnancy and resulted in a birth irregularity.
What Are The Figures Of Cleft Palate Vs CHDs Associated With Zofran In Pennsylvania?
Again, based on our estimates above, we believe there may be as many as 2,000 orofacial cleft (cleft palate / cleft lip), and 4,000 ASD or VSD also known as congenital heart defects (CHDs) that may have been occurred due to Zofran usage in the first three months of pregnancy.
Below is a breakdown by largest city:
- Philadelphia – 700 infant birth deformities (approx. 150 clef palate and 550 CHDs)
- Pittsburgh – 150 infant birth deformities (approx. 30 cleft palate and 120 CHDs)
- Allentown – 60 infant birth deformities (approx. 10 cleft palate and 50 CHDs)
- Erie – 50 infant birth deformities (approx. 10 cleft palate and 40 CHDs)
- Reading – 40 infant birth deformities (approx. 5 cleft palate and 35 CHDs)
What Have Been The Disclosed Negative Effects Of Using Zofran?
Despite the many clinical studies that have conducted about the effects of Zofran on babies, GSK does not acknowledge that their drug is the cause of the birth abnormalities that have been established in the clinical studies. As stated above, lawsuits have been pouring in about that have seen litigants state that Zofran caused birth defects. Some of the disclosed defects have been:
- Hole in the heart defects
- Renal malformations
- Low set ears
- Facial dysmorphia
- Club foot
- Cleft lip
- Cleft palate
For more information view the complaint here.
For cleft palate especially Zofran has been linked to double the chances of a baby being born with a cleft palate in a study conducted by CDC and Epidemiology Center in 2012. Read about the report here.
How Do I Know If I Have A Lawsuit To File?
If it is definite that Zofran was used in the early stages of pregnancy (first trimester) and a baby was born with birth irregularities like Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) and orofacial cleft, among others, then you may have a Zofran case to bring to court for settlement.
Please get in touch with us as soon as you can for a no cost case evaluation.
If your child suffered other complications, please call us. We are investigating other child birth defects that are related to Zofran and may be able to guide you.
Who Are The Pennsylvania Zofran Lawyers
With lawyers licensed to practice law and offices in Pennsylvania, Monheit Law is currently taking Zofran birth defect cases from families living in Pennsylvania. To read more about our PA licensed attorneys, click here.