Zofran Birth Defects and Other Issues

Zofran birth defectsMuch of the Zofran controversy stems from the FDA discontinuation of the drug in certain cases. Zofran Oral Solution, a selective 5-HT3 receptor antagonist, is indicated for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin ≥50mg/m2; prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy; prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen; and prevention of post-op nausea and vomiting.

Zofran Side Effects

In addition to being linked to birth defects in babies exposed to the drug in the womb, Zofran may cause a number of serious side effects in users. Specifically, Zofran has been linked to cardiac arrhythmias and serotonin syndrome, which can be harmful to both the mother and fetus. In June 2012, FDA issued a warning regarding a potential link between Zofran and an increased risk of prolongation of the QT interval, which can cause the potentially fatal arrhythmia Torsade de pointes. FDA warned physicians to avoid prescribing Zofran to patients with congenital long-QT syndrome, and recommended ECG monitoring for users with electrolyte abnormalities, such as hypokalemia or hypomagnesemia.

Although Zofran is not approved to treat morning sickness, it is commonly prescribed “off-label” for this purpose. In fact, it has been estimated that approximately 1 million pregnant women are prescribed Zofran each year to relieve the symptoms of morning sickness, specifically nausea and vomiting. Off-label prescribing is legal and done at the doctor’s discretion; however, when used in this capacity, Zofran has been linked to birth defects.

Birth Defect Studies

  • Hong Kong-based study published in 2006 found that Zofran readily crosses the human placenta during the 1st trimester of pregnancy. Traces of the drug were found in every sample of fetal tissue taken from 41 test subjects.
  • Epidemiological study of more than 10,000 birth records performed by researchers at Harvard and Boston University links Zofran to a 2.37-fold increased risk of cleft palate.
  • Zofran associated with a 20% increased risk of kidney defects and other congenital abnormalities in a study published in BioMed Research International.
  • In 2013, a Danish Study titled “Ondansetron use in early pregnancy and the risk of congenital malformations”found a 2-fold increased risk of heart defects in babies whose mothers used ondansetron in pregnancy.
  • June 2014 study published in the Toronto Star finds at least 20 women who took Zofran for vomiting in pregnancy had children with birth defects, including 2 infant deaths and multiple cases of heart and kidney malformations. Four of the babies weighed as little as 4.5 lbs. In 6 cases, the birth defect was characterized as “fetal growth restriction.”
  • In December 2014, Reproductive Toxicology publishes the ‘Anderson Study’ which links ondansetron use during the 1st trimester to a doubled risk for atrial and ventricular septal heart defects, collectively known as “hole in the heart” defects.
  • Medical practice guidelines advise physicians to use caution when prescribing Zofran, saying the drug should be used only after all other options for treating morning sickness have been exhausted.

From January 1, 1991 to April 30, 2015, the 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 Decreased” 
  • 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 Carries
  • 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
  • Haematochezia
  • Duodenal Atresia
  • Large Intestinal Atresia
  • Ileal Atresia
  • Abdominal Pain
  • Oesophageal Atresia
  • Dysphagia
  • Pyloric Stenosis
  • Gastric Ulcer
  • Gastrosophageal 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

Craniofacial Defects

A review of FDA adverse event data for Zofran identified at least 52 references to craniofacial birth defects and associated anomalies, including:

  • 7 references to Cleft Lip and Cleft Palate occurring together
  • 4 references to Isolated Cleft Palate – Split or opening in the roof of the mouth.
  • 7 references to Microcephaly – Condition in which the baby’s head is abnormally small due to insufficient brain growth.
  • 5 references to Deafness Congenital  Hearing loss present at birth.
  • 4 references of Otitis Media – Chronic middle ear infection often caused by Cleft Palate.
  • 3 references to Pierre Robin syndrome – Series of associated defects in which one malformation leads to another, then another and so on. Pierre Robbin involves a cleft palate and either micrognathia (abnormally smaller lower jaw), retrognathia (lower jaw that is set further back than normal) or glossoptis (tongue that sits far back in the throat, obstructing the airway).
  • 3 references to Eustachian Tube Dysfunction – The eustachian tube links the middle ear to the cavity above the roof of the mouth.
  • 3 references to unspecified Ear Formation
  • 2 references to Micrognathia
  • 3 references to Ankyloglossia Congenital or Tongue-Tie – Tongue is “tethered” to floor of mouth by abnormally long strip of tissue.
  • 2 references to Cleft Uvula – The uvula, a teardrop of flesh hanging above the opening to the throat, is “forked” or split.
  • 2 references to unspecified Congenital Nose Malformation or Deformity
  • 2 references to unspecified Speech Disorder or Speech Disorder Developmental
  • 2 references to unspecified Tooth Disorder or Malformation
  • 2 references to Dental Carries – Tooth decay.
  • 1 reference to Retrognathia
  • 1 references to Glossoptis
  • 1 reference to Upper Airway Obstruction – Occurs when the upper breathing passages become narrowed or blocked, making it hard to breathe.
  • 1 reference to Low Set Ears – Ears are positioned lower on the head than normal.
  • 1 reference to unspecified Skull Malformation
  • 1 reference to unspecified Jaw Malformation
  • 1 reference to Craniosynostosis – Joints between skull bones fuse prematurely.
  • 1 references to Otitis Media Acute – Acute middle ear infection.
  • 1 reference to Lip Ulceration – Small lesions that develop in the lip.

What is a Cleft Palate?

Cleft palate is a congenital birth defect that occurs when a baby’s mouth does not form correctly in the womb. The roof of the mouth, or palate, forms between the 6th and 9th weeks of pregnancy. A cleft palate occurs if the tissue in the roof of the mouth does not join together completely in utero. In some babies with the defect, both the front and back parts of the palate are open. For others, only a portion of the palate remains open after birth. According to the Centers for Disease Control and Prevention (CDC), about 2,650 babies are born with a cleft palate each year in the U.S. Isolated orofacial clefts, or clefts that occur with no other major birth defects, are among the most common types of birth defects in the U.S.

Treatment

Successful treatment of orofacial defects requires several years and multiple surgeries to provide a satisfactory outcome. Cleft palate repair requires a number of surgeries, the first of which should be performed when the child is between 6 months and 1 year old. The 1st surgery typically involves repairing the defect in the palate, which improves feeding and weight gain, and reduces hearing loss and ear infections. Palate repair also improves development of the upper jaw and facial bones.

At about 8 years of age, a bone graft is done to support the upper jaw structure and help with speech articulation. Braces may be used to straighten permanent teeth, and surgical scar removal may be performed later in life to improve cosmetic appearance.

Zofran Heart Defects

Of the 475 birth defects linked to Zofran, 170 involved malformations of the heart and cardiovascular system including:

  • 44 references to Cardiac Septal Defects – Involve cardiac walls that failed to form properly in the womb.
  • 21 references to Ventricular Septal Defects – Holes in the wall that separate the heart’s lower chambers, or ventricles.
  • 16 references to Atrial Septal Defects – Occurs when a hole remains in the wall that would normally separate the heart’s 2 upper chambers, the atria.
  • 12 references to Cerebral Hemorrhage or Cerebral Hemorrhage – Type of stroke in which the bursting of an artery within the brain leaks blood into surrounding tissue.
  • 7 references to Haemangioma – Birth mark that often appears red and rubbery, caused by the excessive growth of cells lining arteries and veins.
  • 6 references to Atrioventricular Septal Defects (ASVD) – Hole in the heart’s center, where the atria on top meet the ventricles below.
  • 6 references to Cardiac Murmur –  Abnormal sound of blood flowing improperly through the heart; often a symptom of underlying cardiac septal defect.
  • 5 references to Hypotension – Abnormally low blood pressure.
  • 5 references to Fetal Heart Rate Abnormal  – Fetal heart rates that are irregular.
  • 4 references to Platelet Count Increased – Platelets are a type of blood cell that allow the blood to clot after injury.
  • 4 references to Cardiac Flutter or Atrial Flutter – Abnormal heart rhythm that begins in the heart’s atria.
  • 3 references to Pulmonary Valve Stenosis – Malformation that restricts blood flow from the heart to the lungs, typically caused by a valve that is thicker than normal or fails to open properly.
  • 3 references to Reticulocyte Count Increased – Reticulocytes are immature red blood cells that develop in bone marrow.
  • 3 references to Coarctation of the Aorta (COA) – Abnormally narrow aorta (large blood vessel that transports blood from the heart to the rest of the body).
  • 3 references to Hypertension Neonatal – Abnormally high blood pressure.
  • 3 references to Bradycardia – Abnormally slow heart action.
  • 3 references to Heart Rate Increased – Elevated heart rate.
  • 2 references to Pulmonary Artery Stenosis – Abnormal narrowing in the pulmonary artery.
  • 2 references to Pulmonary Hypertension – High blood pressure affecting the heart’s right side and arteries in the lungs.
  • 2 references to Patent Ductus Arteriosus (PDA) – The ductus arteriosus is a blood vessel that allows blood to circumvent the lungs while babies are in the womb. After birth, the vessel closes within a couple days. In children with PDA, the vessel does not close.
  • 2 references to Left Ventricular Hypertrophy – Thickening and enlargement of walls in the heart’s left ventricle.
  • 2 references to Ventricular Hypoplasia or Hypoplastic Left Heart Syndrome (HLHS) – Occurs when the heart’s left ventricle is severely underdeveloped.
  • 2 references to Congenital Aortic Valve Incompetence – Aortic valve defect in which allows blood to leak back in the left ventricle after being pumped into the aorta.
  • 2 references to Congenital Tricuspid Valve Atresia – In a healthy heart, blood flow between the right ventricle and atrium is controlled by the tricuspid valve. Babies born with tricuspid valve atresia don’t have this valve, but a solid sheet of tissue instead.
  • 2 references to Tetralogy of Fallot (TOF) – Series of the following 4 congenital heart defects occurring together: Ventricular Septal Defect, Pulmonary Stenosis, Right Ventricular Hypertrophy and an Overriding Aorta, in which the aortic valve is enlarged.
  • 2 references to Shone’s Complex – Combination of 4 defects of the heart’s left side occurring together: Coarctation of the Aorta, Subaortic Stenosis, Parachute Mitral Valve (abnormal ring of tissue surrounding the mitral valve).
  • 2 references to Thrombocytopenia – Abnormally low platelet count.
  • 2 references to Fetal Arrhythmia – Abnormal heart rhythm.
  • 2 references to Hemoglobin Decreased – Hemoglobin levels below lowest level for age and sex.
  • 1 reference to Anomalous Pulmonary Venous Connection – Occurs when veins that transport blood from the lungs to the heart attach at abnormal locations.
  • 1 reference to Arterial Stenosis – Abnormal narrowing in an artery.
  • 1 reference to Pulmonary Artery Atresia – Malformation of the pulmonary valve in which the valve orifice fails to develop.
  • 1 reference to Bicuspid Aortic Valve – The aortic valve, which lies between the heart and aorta, normally has 3 flaps or “leaflets.” In this defect, the valve only has 2 flaps and cannot open properly.
  • 1 reference to Mitral Valve Disease – The mitral valve is located between the left ventricle and atrium, controlling blood flow between the 2 chambers.
  • 1 reference to Dextrocardia – The heart points to the body’s right side, rather than to its left as is normal.
  • 1 reference to Wolff-Parkinson-Whiye Syndrome – Extra electrical pathway leading between the atria and ventricles, often resulting in tachycardia (abnormally fast heartbeat).
  • 1 reference to Arterial Thrombosis – Blood clot in the artery.
  • 1 reference to Persistent Fetal Circulation – Condition that occurs when the body fails to change from the circulation patterns before birth to those that normally develop shortly after birth.
  • 1 reference to Peripheral Venous Disease – Malformation which involves defects that prevent blood from flowing from the hands and feet to the heart properly.
  • 1 reference to Poor Peripheral Circulation – Inadequate blood flow to the body’s extremities and skin.
  • 1 reference to Thrombocytosis – Disorder in which the body produces too many platelets.
  • 1 reference to Coagulopathy – Disorder in which the blood’s ability to clot is impaired.
  • 1 reference to Hemoglobin Increased – Hemoglobin is a protein that allows red blood cells to carry oxygen.
  • 1 reference to Blood Potassium Increased – Potassium is both a mineral and electrolyte that helps maintain the amount of water inside and outside of cells.
  • 1 reference to Hematocrit Decreased or Haematocrit Decreased – Hematocrit is the volume percentage of red blood cells in blood.
  • 1 reference to Naevus Flammeus – Birthmark caused by abnormally stretched capillaries.
  • 1 reference to unspecified Cardiac Septal Defect

The Danish study noted above, “Ondansetron use in early pregnancy and the risk of congenital malformations,”found that babies who were exposed to Zofran in the womb during the 1st trimester of pregnancy were twice as likely to be born a with congenital heart defect compared to babies who were not exposed to the drug.

The study’s authors looked at nearly 900,000 pregnancies in Denmark that occurred between 1997 and 2010. About 1,250 women reported taking Zofran during their 1st trimester, including 58 (4.7%) who had a baby with a birth defect. The rate of birth defects was 30% higher for Zofran users compared to non-users, mostly due to a 2-fold increased rate of heart defects.

Symptoms of a Heart Defect

  • Heart murmur
  • Failure to thrive
  • Shortness of breath
  • Paleness
  • Cyanosis
  • Rapid heartbeat
  • Sweating while feeding

Kidney Defects

Zofran has been linked to at least 60 cases of kidney and associated defects, including:

  • 48 references to Congenital Kidney and Bladder Defects and Abnormalities
  • 12 references to Hydronephrosis or Hydroureter – Obstruction in the kidneys blocks the flow of urine, causing the organ to swell.
  • 8 references to Metabolic Acidosis or Late Metabolic Acidosis of Prematurity – Kidneys are unable to remove sufficient amounts of acids from the blood.
  • 4 references to Pelvic Kidney – Kidney that remains in the pelvic area, rather than ascending upward as in normal fetal development.
  • 3 references to Renal Cyst – Sac of fluid in the kidneys.
  • 2 references to Urinary Tract Infection (UTI)
  • 3 references to unspecified Urinary Tract Disorder or Malformation
  • 2 references to unspecified Congenital Bladder Anomaly
  • 1 reference to unspecified Kidney Malformation.
  • 1 reference to Kidney Duplex – 2 ureters attached to a single kidney.
  • 1 reference to Single Kidney Function – Only 1 kidney works.
  • 1 reference to Bartter’s Syndrome – Malformation that inhibits kidney function.

Gastrointestinal Defects

FDA adverse event data lists 72 references to gastrointestinal defects and related abnormalities which included:

  • 9 references to Gastroschisis – Portions of the intestines protrude outside the body through a hole in the abdominal wall.
  • 9 references to Anal Atresia – Anus is either completely absent or in an abnormal place.
  • 7 references to Intestinal Obstruction – Partial or total blockage in the bowels.
  • 6 references to Gastrosophageal Reflux Disease or Acid Reflux – Stomach contents leak from stomach back into esophagus.
  • 5 references to unspecified Gastrointestinal Disorder Congenital
  • 5 references to Anal Fistula – Infected tunnel between the skin and anus.
  • 3 references to Necrotising Enterocolitis Neonatal – Defect in which portions of the bowel tissue undergo premature cell death.
  • 3 references to unspecified Anorectal Disorder
  • 2 references to Duodenal Atresia – First part of the intestine is either absent or abnormally closed.
  • 2 references to Pyloric Stenosis – The valve between the stomach and small intestine is abnormally thick, blocking the passage of blood.
  • 2 references to Enterocolitis – Inflammation of the small intestine and colon.
  • 2 references to unspecified Abdominal Wall Anomaly
  • 2 references to Abdominal Pain
  • 2 references to Dyspepsia – Indigestion.
  • 1 reference to Congenital Inguinal Hernia – Opening in groin muscles fails to close, causing intestinal muscles to push forward, creating a bulge.
  • 1 reference to Intestinal Fistula – Abnormal passage or connection between 2 body parts that are not normally connected.
  • 1 reference to Haematochezia – Passage of fresh blood through the anus, usually in or with stool.
  • 1 reference to Large Intestinal Atresia – Large intestine is either absent or abnormally closed.
  • 1 reference to Ileal Atresia – The small intestine’s small segment, the ileum, is either absent or abnormally closed.
  • 1 reference to Oesophageal Atresia – The esophagus or “gullet” connects the throat to the stomach. In this defect, the esophagus ends in a closed pouch rather than connecting to the stomach.
  • 1 reference to Dysphagia – Difficulty swallowing.
  • 1 reference to Gastric Ulcer – A break or sore in the lining of the intestines, esophagus or stomach.
  • 1 reference to unspecified Congenital Intestinal Malformation

Limb Defects

At least 20 cases of congenital limb defects and abnormalities have been linked to Zofran, including 7 cases of clubfoot or “talipes,” a condition in which one or both of the baby’s feet appear twisted inward.

Respiratory Defects

At least 86 reports of congenital respiratory defects have been linked to Zofran, including:

  • 24 references to Neonatal Respiratory Distress Syndrome – Inadequately developed lungs causing breathing difficulties.
  • 17 references to Neonatal Apnea or Apnea of Prematurity – Problems with temperature regulation, acquisition of oral feeding skills and the normal control of respiration.
  • 5 references to Congenital Diaphragmatic Anomaly or Disorder – Malformation of the diaphragm, a sheet of muscle that separates the chest from the abdomen.
  • 5 references to Pulmonary Hyperplasia – Lungs develop only partially.
  • 5 references to Pulmonary Hypoplasia – Incomplete development of the lungs.
  • 3 references to Neonatal Respiratory Depression – Dangerous low breathing rate in newborns.
  • 3 references to Tachypnoea or “Transient Tachypnoea of the Newborn” – Temporary rapid breathing of the newborn.
  • 3 references to Congenital Pneumonia – Lung infection in a neonate.
  • 3 references to Cyanosis Neonatal – Blue or purple skin coloration due to insufficient levels of oxygen reaching the skin.
  • 3 references to Tracheomalacia – Improper development of the cartilage in the windpipe (trachea).
  • 2 references to unspecified Respiratory Disorder Neonatal
  • 2 references to Respiratory Arrest – Complete cessation of normal breathing.
  • 2 references to Asthma – Condition in which the airways become inflamed, narrow and swell, and produce extra mucus.
  • 2 references to Neonatal Respiration – Defect in which babies are born with meconium (a baby’s first feces) in the lungs.
  • 2 references to Meconium Stain or Meconium in the Amniotic Fluid – Symptom of neonatal aspiration.
  • 1 reference to Bradypnoea – Abnormally slow breathing rate.
  • 1 reference to Obstructive Airway Disorder or Obstructive Lung Disease – Respiratory condition in which breathing is impaired.
  • 1 reference to Dyspnoea – Difficult or labored breathing.
  • 1 reference to Bronchospasm – Sudden constriction of the passageways that deliver air from the nose or mouth to the lungs.
  • 1 reference to Neonatal Hypoxia – Oxygen levels insufficient to meet physical demands.
  • 1 reference to Diaphragmatic Aplasia – Failure of the diaphragm to develop or function properly.
  • 1 reference to Immature Respiratory System – Irregular breathing caused by underdeveloped lungs.
  • 1 reference to Pneumothorax – Collapsed lung.
  • 1 references to Bronchopulmonary Dysplasia – Inflammation and scarring of the lungs.
  • 1 reference to unspecified Lung Disorder

Reproductive System Defects

Zofran has been associated with 39 cases of reproductive system birth defects including:

  • 18 reports of Hypospadias – Condition in males in which the opening of the urethra is on the underside of the penis.
  • 6 cases of Cryptochidism – Absence of one or both testes from the scrotum.

Other Adverse Fetal Outcomes

382 references to “other adverse fetal outcomes” including:

  • 55 references to Fetal Death, Stillbirth, Spontaneous Abortion or Missed Abortion
  • 73 references to Premature Babies
  • 63 references to Fetal Growth Restriction (fetal weight below 10th percentile for gestational age)
  • 21 reports of unspecified congenital anomalies

Guidance Information for Expecting Mothers

FDA has issued the following guidelines for patients who have been prescribed Zofran:

  • Discuss the drug with your physician or healthcare professional and to not stop taking the drug without first discussing it with your doctor or healthcare professional.
  • Be aware that physicians might order an electrocardiogram (ECG, EKG) to monitor heart rate and rhythm. Moreover, physicians might order such tests for patients with electrolyte abnormalities, congestive heart failure, or bradyarrhythmias.
  • Immediately contact your healthcare professional or seek emergency care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking Zofran / Ondansetron.

Have Any Medications Been Approved to Treat Morning Sickness?

Yes. In April 2013, Diclegis (generic: doxylamine and vitamin B6) became the first FDA-approved drug to treat nausea and vomiting in pregnancy. Diclegis was originally introduced in 1956, but it was pulled off the market in 1983 amid product liability lawsuits, only to return again with the FDA’s approval.

“Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety,” said Canadian physician and medical researcher Dr. Gideon Koren, who was part of a research team that investigated Zofran birth defects.

Has Zofran Been Recalled?

In 2012, FDA issued a recall for the 32 mg intravenous dose of Zofran due to the “potential for cardiac risks.”The abnormal rhythm disorder is known as QT interval prolongation and can lead to Torsades de Pointes, a potentially fatal abnormal heart rhythm.

Allegations

Court documents indicate that Glaxo was aware as early as 1992 that Zofran had been linked with an “unreasonable risk of harm” to unborn babies because the it passes through the human placenta during pregnancy. However, the company continued to promote the drug to pregnant women for morning sickness.Among other things, Zofran lawsuits allege:

  • That GSK had a legal obligation to ensure that Zofran was safe before releasing it, and failed to determine its safety risks before promoting it.
  • That the company failed to adequately warn the public and medical communities about the risk of Zofran side effects.
  • That Glaxo marketed Zofran as a safe treatment for morning sickness and hyperemesis gravidarum even if it had not been approved by the FDA for this use.
  • That GSK misrepresented animal studies indicating that Zofran was safe, when in reality the studies showed abnormal bone growth and signs of toxicity.
  • That Glaxo failed to properly analyze all data and safety information regarding Zofran use in pregnant women.
  • That the company manufactured a defective drug, and
  • Falsely and fraudulently claimed it was safe for pregnant women.

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