Zofran (generic: ondansetron), an anti-nausea drug, has been linked to severe congenital birth defects including cleft palate and heart problems. Studies indicate that women who use Zofran during pregnancy may be up to 30% more likely to give birth to babies with these defects.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: New Cases Added to Zofran MDL in Boston
February 12, 2016 – At least 9 new birth defect lawsuits have been added to the Zofran multidistrict litigation (MDL) already this month. Of the 9 complaints, only 1 was originally transferred from another court. The other 8 were filed directly into the MDL last week. The litigation now includes at least 224 lawsuits, according to the court docket.
What is Zofran?
Zofran is a prescription anti-nausea drug made by GlaxoSmithKline (GSK). It was approved by the U.S. Food & Drug Administration (FDA) in 1991 for the treatment of nausea and vomiting in patients recovering from surgery or chemotherapy. Zofran works by blocking serotonin, a neurotransmitter in the body that causes vomiting.
What’s the Problem?
Zofran has never been approved to treat morning sickness, but is often prescribed “off label” to pregnant women for this purpose. Off-label prescribing is legal and done at the doctor’s discretion, but it is illegal for pharmaceutical companies to market their drugs for off-label indications. Unfortunately, studies have shown that when taken early in pregnancy (particularly during the 1st trimester, a time when many women are still unaware they are pregnant), Zofran may cause serious congenital birth defects.
- A 2006 Hong Kong-based study titled “Placental Transfer of Ondansetron During Early Human Pregnancy” looked at 41 patients who took Zofran before surgical termination of their pregnancy during the first trimester. The drug was found in all 41 fetal samples. Researchers concluded that Zofran readily crosses the human placenta during the first trimester of pregnancy, the most critical time for fetal development.
- A Nov. 2011 study published in Birth Defects Research that looked at prescription drugs used to treat morning sickness found a 2.4-fold increased risk of cleft palate associated with Zofran use during pregnancy.
- In Dec. 2013, a study titled “Off-Label use of Ondansetron in Pregnancy in Western Australia” identified a 20% increased risk of major birth defects amongst children exposed to Zofran in the first trimester. However, this estimate was based on small numbers and was imprecise, with a wide confidence interval.
- 2013 Danish Study which looked at all pregnancies that took place in Denmark from 1997-2010 (903,207 births) found a 2-fold increased risk of congenital heart defects in babies whose mothers used Zofran in their first trimester.
- Dec. 2014 study that looked at data from the Swedish Medical Register found an increased risk of “a cardiovascular defect and notably a cardiac septum defect” associated with Zofran use during pregnancy.
Zofran Birth Defects
- Heart defects
- Heart murmur
- Atrial septal defect (ASD)
- Cleft palate
- Intrauterine growth restriction (IUGR)
- Kidney defects
- Musculoskeletal anomalies
- Pregnancy complications
- Other birth defects
In addition to being linked to birth defects in babies exposed to the drug in the womb, Zofran has the potential to cause serious side effects in users. In July 2014, the FDA issued a safety warning regarding “serious risks” for women who take Zofran, especially pregnant women with electrolyte imbalances. These risks include serotonin syndrome, a condition marked by cognitive or behavioral changes including confusion, agitation, autonomic instability and neuromuscular changes.
Timeline of Events
- January 1991 – FDA approves Zofran for the treatment of chemotherapy-related nausea and vomiting.
- January 1993 – Pill form of Zofran approved.
- June 1995 – GlaxoWellcome submits New Drug Application for a 4mg/5mL dose of Zofran.
- June 1997 – FDA approves application.
- March 1999 – FDA sends Glaxo warning letter re. its marketing of Zofran. According to the letter, the company failed to warn about the drug’s adverse side effects while touting its effectiveness.
- August 2011 – GSK conducts study titled “A Randomized, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous Ondansetron, a 5-HT3 Antagonist, on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects.”
- September 2011 – FDA issues Drug Safety Communication stating that Zofran may change the heart’s electrical activity, which could lead to abnormal heart rhythms such as Torsade de Pointes. The agency required Zofran labels to be updated to include information about these risks.
- January 2012 – GSK completes its study of Zofran heart risks.
- January 2012 – The National Center on Birth Defects and Developmental Disabilities publishes a report finding that when taken during the 1st trimester, Zofran doubles the risk of cleft palate.
- June 2012 – FDA issues a second Drug Safety Communication stating that the 32 mg dose of Zofran “may affect the electrical activity of the heart (QT interval prolongation).”
- July 2012 – U.S. Department of Justice issues a press release stating that GSK would pay a $3 billion settlement after pleading guilty to improperly marketing Zofran off-label for morning sickness and paying doctors to prescribe the drug.
- December 2012 – FDA issues another Drug Safety Communication stating that 32 mg brand name and generic versions of Zofran were being recalled because of the drug’s potential to cause abnormal heart rhythms.
- August 2013 – Two papers relating to Zofran birth defects are presented at the International Society for Pharmacoepidemiology (ISPE). The 1st paper finds that Zofran was not linked to an increased risk of adverse fetal outcomes. The 2nd paper includes data from the 1st, but covered more years and test subjects, and reached the opposite conclusion: that there is a doubled risk of cardiac malformations. Specifically, there was a significant increase in the occurrence of major congenital heart defects in children whose mothers took Zofran during in the 1st trimester of pregnancy.
- July 2014 – American researchers confirm prior reports that Zofran crosses the placental barrier during pregnancy in relatively high concentrations after just 3 oral doses. The study’s authors conclude that the high lipid solubility of Zofran increases its ability to be taken up into fetal tissue in larger amounts.
- August 2014 – A Swedish study investigating Zofran birth defects reports that the drug poses a significantly increased risk for cardiac septum defects in babies born to women who used Zofran in the 1st trimester of pregnancy.
Zofran Lawsuit Filed in Alabama
A product liability lawsuit has been filed in U.S. District Court in Northern Alabama on behalf of woman who alleges her son was born with significant birth defects after she took Zofran in pregnancy. Plaintiff Julie Hunter started taking Zofran during the early part of her pregnancy in January 2006, according to the complaint. Hunter’s son Talon was born in August, and diagnosed shortly thereafter with a number of severe birth defects. Click here to learn more.
Texas Couple Alleges Zofran Caused Death of One Daughter, Kidney Defects in Another
A Texas couple has filed a lawsuit alleging that the mother’s use of Zofran in pregnancy caused the death of their first daughter and life-threatening kidney defects in their second. The plaintiffs are seeking damages in excess of $75,000 from GSK, as well to have the labeling of Zofran changed to include information about the risks of taking the drug while pregnant. Click here to learn more.
Questions of Fact
Questions of fact are questions regarding what happened during the series of events that ultimately led to a lawsuit. Each Zofran lawsuit contains the following questions of fact:
- Did Zofran cause a birth defect in an unborn child?
- Did GSK unlawfully market Zofran “off-label” for morning sickness treatment?
- Did GSK hide evidence that Zofran causes birth defects?
- Did GSK fail to warn of the alleged side effects?
Do I Have a Zofran Birth Defects Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and we can help.