A staggering number of families have made claims against the drug manufacturing company GlaxoSmithKline. These claims are centered around GlaxoSmithKline’s drug Zofran (the generic form of which is named ondansetron and is commonly used to prevent nausea, vomiting and other sicknesses in cancer patients during various cancer surgeries, chemotherapy and radiation therapy) and that Zofran factored into negative effects as a result of being prescribed and consuming the drug while pregnant, particularly in terms of various types of birth defects.
Zofran is a drug that frequently can be prescribed and used in attempts to cure morning sickness in pregnant females. Many of the women are prescribed Zofran during their first trimester (due to the large amount of nausea and overall morning sickness experienced during that specific period of their pregnancy). Furthermore, research has found that during the first trimester of the pregnancy the fetus is its most vulnerable. Thus the fetus can be negatively affected by outside elements that factor into proper human development, such as the Zofran drug taken by their pregnant mothers during pregnancy.
The FDA has recognized Zofran a Category B pregnancy medication. This recognition has been given to Zofran because a properly controlled testing of the drug’s safety is unavailable to be done on pregnant women. Although, researchers have continued to examine the effects of Zofran by observing infants, whose mothers took Zofran, after their birth. Many researchers have found an increase in negative effects among those infants, when compared to infants whose mothers did not take Zofran during pregnancy. The birth defects of Zofran include:
- Cleft lip
- Cleft palate
- Spina bifida
- Kidney malformations
- Webbed toes
- Heart defects
- Facial dysmorphia
- Blood pressure abnormalities
- Club foot
- Vision issues
- Mental problems
- Hearing loss
- Heart defects
- Persistent pulmonary hypertension of the newborn (PPHN)
- Craniosynostosis
- Fetal death
In 2012, GlaxoSmithKline plead guilty to criminal charges. GlaxoSmithKline plead guilty due their mismarketing of multiple products, one of the products being Zofran, for uses that were overall found to be unapproved. The company was fined because of their unethical marketing and other serious offenses and as a result had to pay out $3 billion (the largest amount against a pharmaceutical company).
Currently, lawsuits against GlaxoSmithKline because of negligence and the negative side effects caused by Zofran are in the early stages and more claims are being brought weekly. If your child or a family member are experiencing negative outcomes or side effects due to using Zofran, please contact us at 616-227-8444 or via our web page at www.naumeslaw.com for a free consultation.