Zofran Birth Defects

For additional Zofran information, visit our other Zofran pages: Zofran Lawsuits, Zofran studies, Should I Take Zofran While Pregnant?, or What Types of Birth Defects are Associated with Zofran Use?

It is extremely important that doctors do not prescribe medications to pregnant mothers that could be dangerous to the infant.  It is even more important for healthcare providers and medication manufacturers to properly address the risk of medications and birth defects and not recommend medications that could be harmful.

One of the most concerning medications commonly prescribed to pregnant women is Zofran (ondansetron).  Doctors most often prescribe Zofran to individuals who are undergoing chemotherapy, who have recently undergone surgery or who are suffering from nausea, including pregnant women.  Pregnant women experiencing severe symptoms of morning sickness often take anti-nausea medication during the first trimester.

Although Zofran has shown effectiveness in treating nausea and vomiting, recent studies indicate that it also comes with a serious risk of side effects to both mother and infant.  What’s more, the U.S. Food and Drug Administration (FDA) has not approved this medication for use during pregnancy.

How Zofran Works

Zofran works by blocking chemicals in the body responsible for nausea and vomiting.  The main function of the medication is to treat patients with cancer, who have surgery, or who are undergoing chemotherapy or radiation.  These patients often experience severe nausea.

Patients take Zofran orally via a rapidly disintegrating tablet (ODT), or through injections.  Pregnant women experiencing nausea and/or vomiting usually take the oral tablet, which typically starts around 8 mg per tablet.

Although no one knows exactly why pregnant women experience nausea and/or vomiting, research suggests that more 50 percent of all pregnant women will experience a bout of nausea during pregnancy.  In instances in which nausea is severe and home remedies fail to work, women may be prescribed Zofran or similar medications.

Zofran Warnings

According to the FDA, taking Zofran while pregnant can potentially lead to serious birth defects.  Yet many doctors still frequently prescribe it.  Even worse, since morning sickness is most common during the first trimester of pregnancy, women taking Zofran do so during an infant’s most crucial development period.

It is important to note that despite its potential risks, the FDA has not stopped Zofran from being prescribed.  However, doctors have the legal duty to inform all pregnant women of the risks associated with Zofran prior to prescribing it.

Common Types of Birth Defects

The most common types of birth defects that can potentially result from Zofran use include:

• Cleft Lip / Cleft Palate – Cleft lip and palate occur as a result of an incomplete formation of the front of the upper jaw and upper portion of the roof of the mouth.
• Jaundice – A buildup of bilirubin (the substance that develops after red blood cells break down). Jaundice causes the skin and eyes to turn yellow. Severe jaundice can lead to kernicterus, a dangerous condition with the potential to cause liver damage, seizures or brain damage.
• Musculoskeletal Anomalies – Deformity or malformation of the musculoskeletal system present at birth.
• Heart Murmurs – A heart murmur is a condition often attributed to structural issues of the heart. The “murmur” sound refers to the sound of abnormal blood flow.
• Atrial Septal Defect, or ASD – ASD occurs when the wall between the two upper heart chambers fails to fully close. Because of the incomplete closure between the two chambers, the infant is born with a gap in the heart.  This “hole” could take multiple surgeries to repair and can lead to long term disabilities due to the lack of oxygen supply to the infant’s brain and body.
• Ventricular Septal Defect, or VSD – VSD is similar to ASD except that the lower two heart chambers experience an incomplete closure of the wall.

Because of the controversial side effects of Zofran, there are numerous studies that aim to gather more substantial results.  A Danish study monitoring 600,000 women taking Zofran found that there isn’t a high risk.  However, the same day that Danish doctors presented their evidence, another group of Danish doctors presented evidence to the contrary.  That study indicates that after following over 900,000 pregnant women who took Zofran, there was a two-fold increase in infant heart defects.

Zofran Complaints and Lawsuits

Some pregnant women find that Zofran eases their nausea and vomiting significantly.  Yet, numerous other women experience tragic adverse events.  There are numerous birth injury lawsuits against GlaxoSmithKline (GSK), the manufacturer of Zofran.  In July 2015, GSK filed a motion to consolidate all Zofran birth defect lawsuits pursuant to Multidistrict Litigation (MDL).  In October 2015, the cases were consolidated into MDL No.  2657.

The motion to consolidate the Zofran pregnancy lawsuits was filed before the U.S. Judicial Panel on Multidistrict Litigation.  The initial consolidation included at least twelve lawsuits alleging that fetal exposure to Zofran led to the development of various birth defects.

In anticipation of other lawsuits for the same general complaints, GSK requested that all current and future Zofran pregnancy lawsuits be consolidated before a single judge to ensure consistency and uniformity.  The filing of this motion to consolidate is somewhat common practice in cases involving mass torts that involve similar allegations and issues.

Zofran Complaints Related to Off-Label Use

In 2012, the United States Department of Justice filed a lawsuit against GSK, which eventually ended in a $3 billion settlement.  According to court documents, the government filed a claim against GSK after it engaged in promoting off-label use of several drugs, including Zofran.

GSK, however, did readily admit that using Zofran for nausea and vomiting in pregnant women has not been tested.  Yet, that didn’t stop them from promoting off-label use of the drug.

“The safety of [Zofran] for use in human pregnancy has not been established… (The company) monitors and reports all adverse event reports,” a representative for GSK stated.

Zofran Complaints Reported in Canada

The safety of Zofran during pregnancy is an issue in Canada as well.  A myriad of women have come forward after experiencing adverse effects after taking the medication.  In fact, along with the risks of birth defects in their infants, other side effects that directly affect the mother include:

• Rashes, hives, and itching
• Shortness of breath
• Body swelling
• Constipation
• Irregular heartbeat
• Dizziness
• Fainting
• Difficulties in breathing and swallowing

At least 20 Canadian women experienced these severe side effects.  One infant also died according to FDA records.  Four infants that were born to mothers who used Zofran weighed around four pounds at birth.  Six infants were said to have “fetal growth restriction.”

“Here is a drug not meant for pregnancy, given in pregnancy, with no data.  So how do you know it’s safe for a baby? It’s an extrapolation that doctors do,” director of Motherrisk, Dr.  Gideon Koren said.

Additional Studies Needed

Zofran is not approved for use during pregnancy by the FDA, but continues to be prescribed during pregnancy for morning sickness.  GSK has received dozens of reports of adverse reactions to the drug since its approval in 1992.  Additional research indicates conflicts in research regarding the safety of Zofran as compared to other similar medications.  Questions regarding the safety of the medication have also resulted in serious inquiry into the ethics and marketing of GSK.

More studies are needed to substantiate the data from previous studies.  Until then, always speak with your doctor regarding whether you should take Zofran while pregnant.  Your physician has a legal obligation to inform you of any risks associated with medications prescribed to you.