Information Web Page For Zofran Lawsuit Claims Purporting Birth Defects Associated Wtih Zofran Including Heart Disease, Cleft Palate and Cleft Lip In Newborns Whose Mothers Used The Medication During Pregnancy To Treat Morning Sickness.
Wright & Schulte LLC would like to announce the launch of a Zofran lawsuits Information webpage to provide the public with important news and information on the birth defects associated with the use of Zofran and the latest developments on Zofran litigation. The law firm notes that Zofran has been prescribed to expectant mothers to treat morning sickness although the drug has not been approved for that purpose.
The attorneys at Wright & Schulte LLC are offering free, no-obligation legal reviews to parents and families whose child experienced Zofran birth defects after taking the nausea medication, including heart defects, cleft lip and cleft palate. To speak with one of the firms attorneys call 1-800-399-0795 or visit yourlegalhelp.com for more information on this and other harmful drugs
- Atrial septal defect (hole in the heart)
- Cleft lip
- Cleft palate
- Fetal growth restriction
- Heart defects
- Heart murmur
- Kidney malformations
- Musculoskeletal defects
- Ventricular Septal Defects (hole between the lower
chambers of the heart)
Zofran, generically known as ondansetron, was approved by the U.S. Food and Drug Administration (FDA) in 1991 to reduce nausea and vomiting in chemotherapy, radiation and surgery patients. Zofran is in a class of medications called 5-HT3 receptor antagonists that work to block serotonin, a natural substance that may cause nausea and vomiting. Zofran is classified under the FDA’s Pregnancy Category B medication, which means its risk to a fetus is not known based on animal reproduction studies and studies on pregnant women. In 2013, the FDA announced it was investigating Zofran for potentially causing serotonin syndrome, a life-threatening event that occurs when drugs that affect a person’s serotonin level are taken at the same time. In 2011, the FDA warned that Zofran may cause abnormal changes in the electrical activity of the heart, which could possibly result in fatal abnormal heart rhythms.
[accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf, September 2011]
Zofran is manufactuered by U.K.-based GlaxoSmithKline (GSK). In 2012, GSK brought civil and criminal penalties against GSK for improperly promoting Zofran and other drugs and for paying kickbacks to physicians to prescribe the company’s drugs. The DOJ accused the company of marketing certain forms of Zofran to treat morning sickness in pregnant women although the medication has only been approved for post-operative nausea. GSK agreed to pay $3 billion to resolve the DOJ’s civil and criminal claims. In announcing the case against GSK, the DOJ said this was the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, July 2, 2012]
Studies on Zofran side-effects have varied on whether the medication causes birth defects. For instance, a study using data from Danish pregnancy, birth, and prescription registries was published in the New England Journal of Medicine in February 2013. The study suggests that Zofran was not associated with a significantly increased risk for birth defects. However, another group of Danish researchers used the same database but examined more cases. As a result, researchers found a two-fold increase in congenital heart defects linked with Zofran during the first trimester of pregnancy. The study also found Zofran increased the risk of birth defects overall by 30 percent. The Toronto Star conducted its own examination of Zofran adverse events reported to the FDA, and discovered at least 20 Canadian women who used Zofran to treat morning sickness suffered serious side-effects that included two infant deaths and multiple cases of babies born with heart disease and kidney malformations.
[nejm.org/doi/full/10.1056/NEJMoa1211035, February 2013]
[clinicalendocrinologynews.com/index.php?id=12242&type=98&tx_ttnews%5Btt_news%5D=221089&cHash=da03e20e36, October 25, 2013]
[thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html, June 25, 2014]
About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free Zofran lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.