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Zofran is an anti-nausea medication that’s currently only approved for use by cancer patients undergoing chemotherapy and other treatments that cause side effects such as nausea and vomiting. Yet, it’s been prescribed to pregnant women as off-label use for morning sickness.

If you’ve been prescribed Zoloft while pregnant, or if your physician has talked to you about taking Zofran for morning sickness, it’s crucial to understand that side effects of the drug and how it may affect your unborn baby.

FDA Warnings on Zofran and Pregnancy

The U.S. Food and Drug Administration (FDA) issued a warning in 2012 regarding the use of Zofran for pregnant women experiencing nausea vomiting, that states there have been numerous risks reported.
pregnant woman

According to the National Institutes of Health (NIH), a fetal safety data study performed on 200 births indicates that there are numerous risks of birth defects if pregnant women take Zofran. In addition, since Zofran is not approved for use by pregnant women, the FDA does not promote it in way for use for morning sickness.

Why Are Physicians Prescribing Zofran to Pregnant Women?

GlaxoKlineSmith, the manufacturers of Zofran, saw a large market for the medication with pregnant women experiencing nausea and vomiting. Although the medication isn’t approved for use by pregnant women, GlaxoKlineSmith began marketing it as such.

In addition, GlaxoKlineSmith reportedly began offering kickbacks to physicians who prescribed the medication to pregnant women. Kickbacks are incentives, including compensation, given to doctors by drug manufacturers in order to promote their medications and products.

However, according to Charlie Ornstein, editor of the non-profit news company, ProPublica, offering kickbacks to doctors is illegal. Yet, giving them money to promote medications is not.

“It’s illegal to give kickbacks to a doctor to prescribe drugs, but it is legal to give money to doctors to help promote your drug. Some doctors make tens of thousands or hundreds of thousands of dollars a year beyond their normal practice just for working with the industry.”

As a result, even though studies indicate that Zofran is linked to a heightened risk of birth defects, physicians continue to prescribe the medication to pregnant women.

GlaxoKlineSmith Previous Lawsuits

GlaxoKlineSmith has created quite a record with promoting medications in a negligent manner. In 2012, the company agreed to pay a $3 billion settlement amount after being found guilty for marketing medications for unapproved uses.

In this particular incident, GlaxoKlineSmith promoted their popular anti-depressant medications Avandia, Paxil, and Wellbutrin for use in children and teenagers, without disclosing studies that the drugs were linked to a heightened risk of suicide for teens and other serious medical risks.

In addition, the company was also required to pay $2 billion in civil liabilities for not adhering to the rules set forth in the False Claims Act. According to Deputy Secretary of the Department of Health and Human Services (HHS), Bill Corr, the lawsuit settlement is a big step forward in stopping drug companies from promoting dangerous prescription medications.

“Today’s historic settlement is a major milestone in our efforts to stamp out health care fraud. For a long time, our health care system had been a target for cheaters who thought they could make an easy profit at the expense of public safety, taxpayers, and the millions of Americans who depend on programs like Medicare and Medicaid. But thanks to strong enforcement actions like those we have announced today, that equation is rapidly changing.”

Birth Defects Associated with Zofran

There are numerous birth defects associated with Zofran, including:

  • Heart defects
  • Cleft lip and cleft palate
  • Abdominal problems
  • Vision problems
  • Deformities of the skull
  • Club foot and webbed toes
  • Hearing loss
  • Mental issues
  • Fetal Growth Restriction
  • Heart defects

The medical costs of caring for infants with birth defects are extremely taxing, and much more than the average family can afford. Per the Centers for Disease Control and Prevention (CDC), around $1.4 billion is spent in one year alone on medical treatment on infants with heart defects.

Furthermore, many infants with birth defects will need long-term ongoing care, including specialized equipment, specialized education, physical therapy, and much more.

The costs of these types of treatments can place a great burden on families, and oftentimes, parents have to take significant time off of work or leave their job altogether to help take care of babies with birth defects and special needs.

Pregnant Women Are Also At Risk

In addition to infants being at risk of developing birth defects, taking Zofran while pregnant has been linked to women developing serious, life-threatening diseases such as serotonin syndrome, seizures, comas, and abnormal heartbeats.

Frequently Asked Zofran and Pregnancy Questions

My baby was born with a heart defect. What does this mean?

Zofran has been linked to a heightened risk of infants developing numerous heart defects. According to one study, around two out of every two hundred women who were prescribed Zofran during pregnancy had an infant born with heart defects. The study indicates that all of the women were taking Zofran during their first trimester to battle nausea.

If your baby was born with a heart defect and you took Zofran while pregnant, there is a chance that the medication caused the condition.

Will taking Zofran during pregnancy cause me to have a miscarriage or stillbirth? 

So far, the evidence is inconclusive regarding Zofran and the risks of miscarriage and stillbirth. However, there have been a few cases in which pregnant women who took Zofran had to terminate their pregnancy due to severe heart malformations and other life-threatening birth defects. Studies regarding miscarriage and stillbirth ongoing.

Will my baby have mental delays or behavioral problems if I took Zofran during pregnancy? 

Keep in mind that your baby’s brain is constantly developing during pregnancy, right up until the end of the third trimester. Therefore, yes, there is a risk of an infant developing mental delays and behavioral problems if you took Zofran while pregnant.

My baby’s father took Zofran. Does that pose any risk to my baby? 

Studies indicate that Zofran only heightens the risk of birth defects and other medical issues if the mother took the medication while pregnant. There is no evidence to suggest that infants will be affected if their father took Zofran when the infant was conceived.

If Zofran is so harmful to unborn babies, why are pregnant women being prescribed it? 

Unfortunately, physicians are legally allowed to prescribe Zofran as long as they prescribe it as off-label use. However, since GlaxoSmithKline suppressed information on the risks of Zofran as well as allegedly ignored numerous studies that indicate how dangerous the drug is to unborn babies, they are now facing numerous Zofran lawsuits.

Should I ask my physician to provide additional prenatal monitoring if I am taking Zofran while pregnant? 

Although we cannot give specific medical advice, we do advise that you speak with your physician if you are worried about the safety of your unborn baby. In some instances, prenatal screenings and ultrasounds, during a routine checkup, have detected medical problems early on.

What to Do If Your Infant Developed Birth Defects

If you took Zofran while pregnant, you have the legal right to file for damages if your baby developed birth defects associated with the drug. An experienced Zofran attorney can help you obtain compensation for medical costs, pain, suffering, economic loss, and more.

If you’re currently pregnant and taking Zofran, it’s extremely important to understand the risks associated with the medication. Although further studies are needed, prior research indicates that the risk of your infant developing birth defects cannot be ruled out.