Zofran Lawsuit

What is Zofran?

Zofran (generic: ondansetron) is used to prevent nausea and vomiting caused by chemotherapy and radiation treatment, as well as after certain types of surgery. The drug works by blocking one of the body’s natural substances (serotonin) that causes vomiting. Zofran is made by GlaxoSmithKline (GSK), and was approved by the U.S. Food & Drug Administration (FDA) in January 1991.

What’s the Problem?

Pregnant women who take Zofran “off-label” for morning sickness may be unknowingly exposing their unborn babies to an increased risk for a large number of severe, potentially life-threatening birth defects.

Zofran Birth Defects

From January 1, 1991 to April 30, 2015, FDA received at least 8,682 reports of adverse events linked to Zofran. Of these, 475 cases (5.4%) involved birth defects including:

Heart Defects
Heart Murmur
Atrial Septal Defect (ASD)
Ventricular Septal Defect (VSD)
Atrioventricular Septal Defect (AVSD)
Cerebral Hemorrhage or Cerebral Hemorrhage Fetal
Anomalous Pulmonary Venous Connection
Pulmonary Valve Stenosis
Pulmonary Artery Stenosis
Arterial Stenosis
Pulmonary Artery Atresia
Pulmonary Hypertension
Hypertension Neonatal
Patent Ductus Arteriosus (PDA)
Left Ventricular Hypertrophy
Ventricular Hypoplasia (also known as “Hypoplastic Left Heart Syndrome,” or HLHS)
Coarctation of the Aorta (COA)
Bicuspid Aortic Valve
Congenital Aortic Valve Incompetence
Congenital Tricuspid Valve Atresia
Tetralogy of Fallot (TOF)
Mitral Valve Disease
Shone’s Complex
Ebstein’s Anomaly
Dextrocardia
Wolff-Parkinson-White Syndrome
Arterial Thrombosis
Cardiac Flutter or “Atrial Flutter”
Cardiac Murmur
Fetal Arrhythmia
Persistent Fetal Circulation
Peripheral Venous Disease
Fetal Heart Rate Abnormal, “Fetal Heart Rate Deceleration Abnormal” or “Heart Rate Dereased”
Bradycardia
Heart Rate Increased
Hypotension
Platelet Count Increased
Thrombocytopenia
Thrombocytosis
Coagulopathy
Reticulocyte Count Increased
Hemoglobin Increased
Hemoglobin Decreased
Blood Potassium Increased
Blood Potassium Decreased
Hematocrit Decreased or “Haematocrit Decreased”
Naevus Flammeus
Haemangioma
Glossoptosis
Musculoskeletal Anomaly
Mouth Deformity
Cleft Palate
Cleft Lip
Deafness Congenital
Pierre Robin Syndrome
Cleft Uvula
Ankyloglossia Congenital or “Tongue-Tie”
Micrognathia
Retrognathia
Upper Airway Obstruction
Congenital Nose Malformation or Deformity
Ear Malformation
Deafness Congenital
Otitis Media Chronic
Eustachian Tube Dysfunction
Low Set Ears
Skull Malformation
Craniosynostosis
Congenital Jaw Malformation
Speech Disorder or “Speech Disorder Developmental”
Tooth Disorder
Dental Caries
Lip Ulceration
Intrauterine Growth Restriction, or IUGR (also known as “Fetal Growth Restriction”)
Poor Peripheral Circulation
Kidney Defects
Hydronephrosis
Hydroureter
Bladder Defects
Hydronephrosis
Metabolic Acidosis or “Late Metabolic Acidosis of Prematurity”
Renal Cyst
Pelvic Kidney
Kidney Duplex
Single Function Kidney
Bartter’s Syndrome
Urinary Tract Disorder
Congenital Bladder Anomaly
Urinary Tract Infection (UTI)
Hypospadias
Gastrointestinal Defects
Gastroschisis
Anal Atresia
Anorectal Disorder
Congenital Intestinal Malformation
Gastrointestinal Disorder Congenital
Abdominal Wall Anomaly
Inguinal Hernia
Intestinal Obstruction
Intestinal Fistula
Anal Fistula
Hematochezia
Duodenal Atresia
Large Intestinal Atresia
Ileal Atresia
Abdominal Pain
Oesophageal Atresia
Dysphagia
Pyloric Stenosis
Gastric Ulcer
Gastroesophageal Reflux Disease or “Acid Reflux”
Dyspepsia
Enterocolitis
Necrotising Enterocolitis Neonatal
Respiratory Defects
Neonatal Respiratory Distress Syndrome
Respiratory Arrest
Lung Disorder
Neonatal Respiratory Depression
Neonatal Apnea or “Apnea of Prematurity” (AOP)
Bradypnoea
Tachypnoea or “Transient Tachypnoea of the Newborn”
Congenital Pneumonia
Asthma
Obstructive Airway Disorder or “Obstructive Lung Disease”
Dyspnoea
Bronchospasm
Cyanosis Neonatal
Pulmonary Hypoplasia
Pulmonary Hyperplasia
Neonatal Hypoxia
Congenital Diaphragmatic Anomaly or Disorder
Diaphragmatic Aplasia
Pneumothorax
Immature Respiratory System
Tracheomalacia
Bronchopulmonary Dysplasia
Neonatal Aspiration
Meconium Stain or “Meconium in the Amniotic Fluid”
Limb Defects
Clubfoot or “Talipes”
Reproductive Defects
Hypospadias
Cryptochidism
Autism
Fetal Death
Stillbirth
Spontaneous Abortion
Missed Abortion
Unspecified Congenital Anomalies
Other Birth Defects

Heart Defects

The following studies have linked the maternal use of Zofran during pregnancy to congenital heart defects:

A study presented at the 2013 International Conference on Pharmacoepidemiology in Montreal found that babies exposed to Zofran during the first trimester were 2.1 times more likely to have atrial septal defects, 2.3 times more likely to have ventricular septal defects, and 4.8 times more likely to have atrioventricular septal defects.
In December 2014, a study published in Reproductive Toxicology concluded that use of Zofran during the first trimester correlated with a 1.62 times increased risk of “cardiac septum defects,” a category of birth defects that includes atrial septal defects, ventricular septal defects and atrioventricular septal defects.
‘Animal teratogenicity studies’ GSK allegedly performed in Japan after Zofran was approved in the U.S. found a link between Zofran and congenital heart defects.

Cleft Palate

A November 2011 study published in Birth Defects Research linked the use of Zofran during pregnancy to a 2.4-fold increased risk of cleft palate. The results were based on data from approximately 9,000 pregnancies, and the research was conducted in conjunction with the Centers for Disease Control and Prevention (CDC).

Kidney Defects

A study published in the Toronto Star in June 2014 found at least 20 women in Canada who had children with birth defects after they took Zofran during pregnancy. Four of the babies weighed 4.5 lbs or less, and in 6 cases the condition was listed as “fetal growth restriction.” Other problems identified by the researchers included congenital kidney defects.

In November 2013, a study published in BioMed Research International looked at birth outcomes of women who took Zofran during pregnancy in Western Australia from 2002 to 2005. The researchers found a “20% increased risk of a major birth defect amongst children exposed to ondansetron in the first trimester,” while acknowledging a relatively small sample size (251 live births) that prevented their findings from being more accurate. While “the study was too small to assess risks of individual birth defects,” the study’s authors also identified a 7-fold increased risk for kidney defects associated with Zofran use during pregnancy.

Side Effects in Users

In addition to the risk of birth defects in babies exposed in the womb, Zofran may also cause the following serious side effects in pregnant women who use the drug:

Zofran Timeline

January 1991 – Approved by the FDA

January 1991 – Zofran (ondansetron) first approved by the U.S. Food & Drug Administration (FDA).

November 19, 2011 – Birth Defects Research study published

November 19, 2011 – Study published in Birth Defects Research links Zofran to a 2.4-fold increased risk of cleft palate.

June 29, 2012 – FDA warning

June 29, 2012 – FDA warns that Zofran may affect the electrical activity of the heart (QT interval prolongation).

August 2013 – Study presented at the International Conference on Pharmacoepidemiology

August 2013 – Study presented at the International Conference on Pharmacoepidemiology links Zofran to an increased risk for atrial septal defects, ventricular septal defects and atrioventricular septal defects.

November 19, 2013 – Biomed Research International study published

November 19, 2013 – Study published in Biomed Research International finds a 20% increased risk of major birth defects associated with Zofran use during the first trimester, as well as a 7-fold increased risk of kidney defects.

June 25, 2014 – Toronto Star study published

June 25, 2014 – Study published in the Toronto Star finds at least 20 women in Canada who gave birth to babies with severe birth defects (low birth weight, fetal growth restriction, kidney defects) after taking Zofran during pregnancy.

September 2014 – Zofran link

September 2014 – Zofran linked to serotonin syndrome.

December 2014 – Reproductive Toxicology study published

December 2014 – Study published in Reproductive Toxicology concludes that use of Zofran during the 1st trimester of pregnancy correlates with a “increased and statistically significant” increased risk of cardiovascular birth defects.