Zofran Causes Birth Defects.

Millions of families have been affected by these tragic, and sometimes fatal, defects.


Risk of Birth Defects

Zofran during pregnancy increases the risk of multiple birth defects including heart defects, septal valve defects, cleft palate and cleft lip, and kidney defects. Zofran pregnancies have a 130% risk of major birth defects.

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Risk of Heart Defects

Zofran during pregnancy more than doubles the risk of Atrial Septal Defects (ASD) and Ventricular Septal Defects (VSD), and increases the risk of Atrioventricular Septal Defects (AVSD) by nearly five times. Serious heart defects can require surgery or can be fatal.

More About Heart Defects

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Risk of Cleft Palate

The National Birth Defects Prevention Study shows more than a doubled risk (237%) of cleft palate for Zofran pregnancies. Children born with a cleft palate can require multiple surgeries and therapy from birth to adulthood to try and fully correct speech and the palate.

More About Cleft Defects

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Risk of Kidney Defects

One study involving 98,000 pregnancies found women using Zofran encountered a six-fold increase in serious kidney defects: obstructive defects of renal pelvic and ureter. Major kidney birth defects can require surgery and cause the loss of function of one or both kidneys.

More About Kidney Defects

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Zofran Was Never Submitted to the FDA for Use During Pregnancy

Zofran was never tested for safety in pregnant women. The manufacturer, GlaxoSmithKline (GSK), did not test if Zofran is safe during pregnancy, nor ask for approval to use in pregnant women. GSK instead promoted the product “off-label” to drive sales of the drug for unapproved uses.

$3 Billion Settlement

In 2012, GSK settled a lawsuit with the United States Department of Justice regarding its promotion of drugs for “off-label” use. Off-label promotion is the selling of a drug in untested populations or for conditions it was never approved. GSK paid $3,000,000,000 to settle its illegal marketing case.

Critical Periods in Human Development

Fetal development during the first trimester contains many critical periods for organ growth. The heart develops during weeks six to eight, and the palate and lip form weeks six through nine. Drugs damaging organ development can lead to major birth defects.

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5 Weeks

fetus week 6

6 Weeks

fetus week 7

7 Weeks

fetus week 8

8 Weeks

fetus week 9

9 Weeks

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16 Weeks

Cleft Lip (~5 to 6 weeks) Upper Lip (~7 to 8 weeks)
Heart (~7 to 9 weeks)
Cleft Palate (~6 to 8 weeks) Palate (~8 to 9 weeks)
Less Sensitive Period
Highly Sensitive Period

Zofran Heart Defects

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*Results from study on Zofran Effects During Pregnancy


Risk of
Heart Defects


Risk of
Atrial Septal Defects


Risk of
Ventricular Septal Defects


Risk of
Atrioventricular Septal Defects

Normal Pregnancy
Zofran Pregnancy

Types of Heart Defects

Common heart defects from Zofran pregnancies include incomplete valve closures between the 4 chambers of the heart. Atrial Septal, Ventricular Septal, and Atrioventricular Septal Defects are major birth defects increased by use of Zofran during pregnancy.

Atrial Septal Heart

atrial septal heart

Ventricular Septal Heart

ventricular septal heart

Atrioventricular Septal Heart

atrioventricular septal heart

Zofran Cleft Palate Defects

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Risk of Cleft Palate within the First Trimester

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normal pregnancy
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zofran pregnancy

Normal Pregnancies

Zofran Pregnancies

More Than Doubles the Risk of Cleft Defects

What Are Cleft Birth Defects?

A cleft palate or cleft lip occurs when tissues of the face do not join properly during development. A cleft can occur on either the left or right. A bilateral cleft palate or lip occurs when the cleft appears on both the left and right side. A child can have cleft lip, cleft palate, or both.

unilateral cleft palate

Unilateral Cleft Palate

bilateral cleft palate

Bilateral Cleft Palate

unilateral cleft lip

Unilateral Cleft Lip

bilateral cleft lip

Bilateral Cleft Lip

Cleft Palate Surgery Schedule

A cleft palate frequently cannot be fixed by a single surgery. A cleft palate can take a team of doctors to perform both surgeries and therapy throughout childhood. Treatment includes soft and hard palate repair, tube insertion, speech therapy, bone grafting, orthodontics, and additional cosmetic surgery.

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* Zofran Cleft Palate Risks - Surgery Schedule
Source: Wikipedia

Zofran Kidney Defects


Increased Risk of Major Kidney Defects

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Six times the Rate of Normal Pregnancies

Types of Kidney Defects

Kidney birth defects from Zofran during pregnancy can cause obstructions of the kidney and ureter. Obstructions of this system causes Hydronephrosis (“water in the kidney”) from the lack of flow of urine out of the system. Extreme cases cause not just organ failure in one or both kidneys, but can also lead to death.


normal kidney disease


mild kidney disease


moderate kidney disease


severe kidney disease

Zofran Lawsuit

Lawyers at Levin Simes are investigating lawsuits regarding birth defects caused by Zofran during pregnancy. We have investigated the studies showing whether Zofran is safe during pregnancy, discovered the birth defects caused by Zofran, and are representing mothers and families affected by the hidden risks of Zofran.

Levin Simes has Recovered $500 Million on Behalf of its Clients

Every state has a time limit on when a lawsuit can be filed. This is called “the statute of limitations” and it varies by state. Contact our firm quickly to make sure the statute of limitations does not run out in your state. Call Levin Simes at 1-888-426-4156 or contact us at [email protected].

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