If you are one of the eighty percent of women who suffered from nausea and vomiting during pregnancy (NVP), your gynecologist or obstetrician might have prescribed Zofran® to alleviate your symptoms. This anti-nausea drug has only been approved by the Food and Drug Administration (FDA) for the relief of nausea and vomiting related to chemotherapy and radiation therapy in cancer patients, as well as nausea from pain medication after surgery. Nonetheless, doctors prescribe Zofran® to an estimated a million pregnant women each year for NVP despite the fact hundreds of lawsuits have been filed by women who have had babies born with physical and cognitive birth defects.
Free Confidential Case Evaluation: If your baby was born with a serious birth defect after you took Zofran® during pregnancy, our seasoned and tenacious bad drug lawyers at Stern Law, PLLC invite you to contact us immediately at 844-808-7529 for a free case evaluation. You may be entitled to financial compensation, and our lawyers can explain your rights and options.
Overview of the FDA Approved Drug Zofran®
The FDA approved Zofran® (generic: ondansetron) for the treatment of nausea related to chemotherapy and radiation therapy, as well as to counteract the effects of pain medication after surgery. Despite a lack of FDA approval for use during pregnancy and a paucity of evidence that the drug is safe for pregnant mothers, the drug manufacturer GlaxoSmithKline (“Glaxo”) actively marketed the drug to women suffering from morning sickness until the FDA leveled a $3 billion dollar fine for illegally promoting the off-label use. Doctors continue to prescribe Zofran®, ondansetron, and the related drug Zuplenz® despite the recent approval of an alternative drug that has been found safe to take during pregnancy after clinical studies.
Why Are Lawsuits Being Filed by Women Who Took Zofran® During Pregnancy?
Zofran® is classified as a “Pregnancy Class B” medication, which means the risks associated with the drug are unknown and that taking the medication during pregnancy is not recommended or approved. Despite the lack of FDA approval for treatment of morning sickness, medical professionals have widely prescribed the drug for this off-label use by expectant mothers. More than 260 women who took Zofran® during pregnancy have filed lawsuits alleging that their babies were born with serious congenital birth defects caused by the medication. Lawsuits pending against Glaxo indicate that the FDA had received hundreds of reports of birth defects among women who took Zofran® for pregnancy-related vomiting and nausea.
Studies suggest use of Zofran® during pregnancy increases the risk of birth defects, such as:
- Atrial Septal Defects (“Hole in the Heart”)
- Ventrical Septal Defects
- Antrioventrical Septal Defects
- Structural Heart Defects
- Tetralogy of Fallot
- Cleft Palate
- Cleft Lip
- Abnormal Heart Rhythm
- Renal Artesia
- Hypoplastic Left Heart Syndrome
- Renal Artresia
- “Fetal Growth Restriction”
- Diaphragmatic Hernia
- Serotonin Syndrome
- QT Syndrome
- Kidney Malformation
- Torsade de Pointes
- Premature Death
- Fetal Death
- Sudden Death
Many of these serious birth defects necessitate risky surgeries, cause lifelong problems, or pose life-threatening risks.
FDA Safety Warning and Adverse Event Reports
While the FDA did issue a safety communication announcing a recall of the 32-mg intravenous dose of Zofran® on December 4, 2012, the agency has issued no other recalls of the drug. The FDA recalled the high dose IV version of Zofran® because it was associated with cardiac risks.
As of July 17, 2015, the FDA had received 475 adverse event reports regarding birth defects and other negative fetal outcomes linked to Zofran®. The FDA also has issued other safety communications regarding use of Zofran® during pregnancy that include:
- September 4, 2012: The agency indicated it was engaged in an ongoing safety review concerning a connection between abnormal changes in the electrical activity of the heart and Zofran®.
- March 2013: The FDA warned of a potential safety issue involving a link between the anti-nausea drug and serotonin syndrome, which can be fatal for both the pregnant mother and fetus.
Studies Linking Use of Zofran® for NVP and Birth Defects
While Zofran® has been linked to many congenital birth defects, the most common examples are heart-related issues and craniofacial defects like cleft lip and cleft palate.
Some studies revealing a connection between Zofran® and birth defects include:
- Hong Kong Study (2006): Researchers confirm that Zofran® passes through the human placenta in significant amounts when used during pregnancy.
- Birth Defects Research (2012): The study reported in the journal found that Zofran® was linked to a 2.4 fold increased probability of cleft palate birth defects. The data used to reach this finding involved 9,000 pregnant women.
- Danish Study Presented to International Conference on Pharmacoepidemiology (August 27, 2013): The study was based on examination of almost 900,000 pregnancies. Researchers found that use of Zofran® during pregnancy doubled the risk of cardiac birth defects. The study also reported a thirty percent increased risk of serious birth defects.
- Biomed Research International (December 2013): The study reported in the journal conducted by Australian researchers concluded Zofran® was linked to a six-fold increase in renal (kidney) malformations. These malformations are obstructive defects that can lead to kidney failure. The study also found a twenty percent increased risk of being born with a major birth defect.
- Reproductive Toxicology (December 2014): Swedish researchers published a study indicating that using Zofran® for morning sickness doubled the risk of septal heart defects (commonly referred to as “hole in the heart” defects).
- American Journal of Obstetrics & Gynecology (December 2014): The study suggested a change in the way the symptoms of morning sickness are treated given FDA approval of a safe alternative (e.g. Diclegis®). Given the existence of a drug, which has been determined to be safer to take during pregnancy, the researchers indicated no reason remained to continue to expose women to use of a drug that did not have a proven record for maternal and fetal safety.
- Reproductive Technology (March 18, 2015): The journal reported a study indicating women taking Zofran® during the 1st trimester of pregnancy increased their risk of having a baby with a birth defect by 62 percent.
Status of Zofran® Birth Defect Lawsuits
At least 260 Zofran® birth defect lawsuits filed in federal courts have been consolidated in a federal Multi-District Litigation (MDL) in Massachusetts. Many other lawsuits have been filed in state courts across the U.S. Court documents filed in pending lawsuits allege that Glaxo was aware that Zofran® posed an unreasonable risk of harm to developing fetuses as early as 1992. Some of the other allegations in pending lawsuits include:
- Glaxo failed to adequately evaluate and review all safety information and data regarding the use of Zofran® during pregnancy.
- Glaxo failed to warn of dangerous side effects associated with the drug.
- Glaxo misrepresented the results of animal studies to suggest Zofran® was safe to take during pregnancy.
- Glaxo fraudulently and falsely represented that the drug was safe to take during pregnancy.
- Glaxo’s advertising misrepresented Zofran® as being a safe treatment for morning sickness.
- Glaxo failed to verify its drug was safe before offering it to the public.
Speak with a Proven and Empathetic Zofran® Heart Birth Defect Attorney
Our Zofran® heart birth defect attorneys at Stern Law, PLLC are accepting lawsuits involving serious birth defects related to use of the anti-nausea drug during pregnancy. Our lawyers can advise you about pursuing an individual lawsuit in state court or joining the MDL litigation in federal court. We represent our clients with passion and diligence in pursuing their rights and full monetary recovery. Our product liability attorneys work tenaciously in pursuit of the best outcome for our clients. We invite you to contact Stern Law, PLLC today at (844) 808-7529 or submit an online form for assistance.