Zofran Side-Effects Lawsuit | Zofran Birth Defects Lawsuit
Zofran Lawsuit, Zofran Side-Effects: Atrial Septal Defect (Hole In The Heart), Cleft Lip, Cleft Palate, Fetal Growth Restriction, Heart Defects, Heart Murmur, Jaundice, Kidney Malformations, Mouth Deformity, Musculoskeletal Defects, Serotonin Syndrome, Ventricular Septal Defects (Hole Between The Lower Chambers Of The Heart), Death
As Zofran lawsuits are filed we’ve learned that studies have shown that women who were treated for morning sickness with Zofran are more likely to have babies born with heart murmur, cleft palate, cleft lip and other birth defects. The attorneys at Wright & Schulte LLC and note that Zofran birth defects lawsuits and have learned that Zofran has never been approved to treat morning sickness, but the medication has been regularly prescribed to expectant mothers during the first trimester of pregnancy. Zofran Side-effects suffered by babies include:
- Atrial septal defect (hole in the heart)
- Cleft lip
- Cleft palate
- Fetal growth restriction
- Heart defects
- Heart murmur
- Kidney malformations
- Mouth deformity
- Musculoskeletal defects
- Serotonin Syndrome
- Ventricular Septal Defects (Hole Between The Lower Chambers Of The Heart)
Wright & Schulte LLC is now investigating Zofran side-effects lawsuits to help families seek compensation for injuries to their newborns caused by the medication. If you or someone you know have a baby who suffered Zofran birth defects, contact Wright & Schulte LLC for a free Zofran side-effects legal evaluation by calling 1-800-399-0795 or you can visit yourlegalhelp.com for more information.
Zofran Birth Defects
Some study findings conflict on whether Zofran causes birth defects in newborns. For instance, a study published in the November 2011 issue of Clinical and Molecular Teratology indicates that babies are twice as likely to be born with a cleft palate due to Zofran use during pregnancy. However, a study published in the New England Journal of Medicine in February 2013 did not link Zofran use with a significantly increased risk of birth defects.
An investigation of Zofran birth-effects by the Toronto Star found 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. The Toronto Star analyzed data from the FDA’s adverse events report for 2012. The investigation, published in June 2014, also found reports of babies born with
- Musculoskeletal anomaly
- Mouth deformity
- Two heart defects, including atrial septal defect (also known as a hole in the heart) Zofran Background
Zofran, generically known as ondansetron, was approved by the U.S. Food and Drug Administration (FDA) in 1991 to prevent nausea and vomiting caused by chemotherapy, radiation and surgery. Zofran, manufacturered by the U.K.-based GlaxoSmithKline (GSK), 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. The FDA never approved Zofran use during pregnancy yet physicians have prescribed the drug “off-label” to expectant mothers to treat morning sickness. GSK was charged in 2012 by the U.S. Department of Justice (DOJ) with illegally promoting Zofran and the company’s other drugs and for paying kickbacks to physicians to prescribe the drugs, among other things. The company agreed to pay $3 billion to resolve the DOJ’s civil and criminal claims.
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. The medication came under investigation by the FDA in 2013 for potentially causing serotonin syndrome and in 2011 for possible causing changes in the electrical activity of the heart which can lead to abnormal, and potentially fatal, heart rhythms. These potentially fatal side-effects can place the health of pregnant women at risk.
[fda.gov/Drugs/DrugSafety/ucm271913.htm, September 15, 2011]
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, July 2, 2012]
[fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm351864.htm, July 10, 2014]
About Wright & Schulte LLC And Filing A Zofran Lawsuit
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 Birth Defects lawsuit or Zofran Side-Effects lawsuit case evaluations are available through this site, yourlegalhelp.com or by calling 1-800-399-0795.