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Thousands of women have been prescribed Zofran for off-label use to treat nausea and vomiting, typically during the first trimester. Many of those mothers-to-be also experienced side effects much worse than nausea and vomiting: severe birth defects. Zofran has been linked to severe birth defects resulting not only in long-term disabilities, but overwhelming medical expenses that the average family cannot afford.

What is Zofran?

Zofran, a 5-HT3 receptor antagonist medication, is a drug manufactured by GlaxoSmithKline for the purpose of treating nausea and vomiting in cancer patients undergoing chemotherapy and radiation therapy.

Zofran works by affecting the serotonin level in the brain, which in turn helps diminish nausea. It was approved in 1991, but only for cancer patients. Yet, the manufacturer, seeing a new market in pregnant women, began pushing the drug for off-label use for nausea and vomiting.
doctor holding baby

Risks of Pregnant Women Taking Zofran

In 2013, Dr. Gideon Koren published an in-depth study regarding the dangers of Zofran if taken while pregnant. The study, which appears in the December edition of the American Journal of Obstetrics and Gynecology, indicated that although there have been numerous conflicting studies performed on the issue, there is no way to rule out the fact that Zofran can lead to birth defects.

In addition, another 2013 study, presented at the International Society of Pharmacoepidemiology indicated that the risks of infants developing congenital heart defects associated with Zofran were increased two-fold.

In an earlier 2012 study performed by the Centers for Birth Defects Research indicates that the risk of infants developing a cleft palate doubles when associated with Zofran. A total of 9,000 women were included in the story, the majority of which experienced nausea and vomiting during the first trimester.

Other birth defects associated with Zofran include:

  • Cleft lip
  • Abdominal problems
  • Vision problems
  • Deformities of the skull
  • Club foot and webbed toes
  • Hearing loss
  • Mental issues
  • Light sensitivity
  • Neural tube defects
  • Developmental delays
  • Musculoskeletal disorders, and more

Cases of Zofran Birth Defects

In February, 2015, a Massachusetts woman filed a personal injury lawsuit against GlaxoSmithKline after her baby was born with numerous birth defects. The mother was prescribed Zofran to help combat nausea and vomiting.

According to court documents, the plaintiff’s infant daughter was born in 2000 with numerous congenital birth defects. The plaintiff states that none of her other previous pregnancy (when she was not prescribed Zofran) resulted in birth defects. Testing indicated that there were no genetic anomalies that would have caused birth defects.

Court documents also indicate that the plaintiff “had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”

Consequently, shortly after birth, the infant was diagnosed with aortic arch hypoplasia, right ventricular hypertension, and atrial septal defect. Throughout the past numerous years, the plaintiff’s daughter has underwent a myriad of surgeries to help the child, who has had significant developmental delays due to the birth defects.

Soon after, three additional women filed their own claims against GlaxoSmithKline after their babies were also born with severe birth defects.

 Zofran and Birth Defects Frequently Asked Questions

What is the link between my baby developing cleft palate and Zofran?

As mentioned earlier,numerous studies in the United States and Denmark have been performed on the link between cleft palate and Zofran. According to the research results of study performed by the Slone Epidemiology Center and the Centers For Disease Control and Prevention (CDC), the risk of infants developing cleft palate doubles if a mother takes Zofran while pregnant.

What is a light sensitivity birth defect and how is it linked to Zofran use? 

Infant light sensitivity is generally caused by elevated pressure in the eyes. Taking Zofran while pregnant may contribute to an infant developing elevated pressure in the eyes, and in turn, developing a sensitivity to light.

How do I know if my baby’s birth defect is linked to taking Zofran? 

There are numerous reasons in which a birth defect can occur, including genetic factors, maternal lifestyle, maternal health, and more. If other contributing factors of birth defects are ruled out by a physician, there is a good chance that your baby’s birth defects are a result of taking Zofran while pregnant. However, only a qualified physician can give a proper diagnosis and confirm the causes of your baby’s birth defects.

Is there a chance my baby will die if I am taking Zofran while pregnant? 

Unfortunately, studies have confirmed that some babies have died from severe heart malformation and other life-threatening birth defects after their mothers took Zofran while pregnant. If you are pregnant and taking Zofran, consider talking to your doctor about changing medications and/or obtaining additional prenatal screening.

My child is older now, but lives with a birth defect. I took Zofran while pregnant. What do I do? 

Regardless of when your child was born, if he/she was born with birth defects and you took Zofran while pregnant, you should contact an experienced Zofran lawyer as soon as possible. An experienced Zofran attorney will help you understand your rights and assist you in determining if your child’s birth defect may have been caused by Zofran.

Keep in mind that GlaxoSmithKline has been promoting Zofran to pregnant women for numerous years now, and there is a good chance that there are many older children who suffer from severe medical problems that started years ago, after their mothers were prescribed Zofran for morning sickness. Although each state has a specific statute of limitations for dangers prescription drug lawsuits, the time limit usually begins from the date that the plaintiff was made aware of the problem, not when the medical issue happened.

Can Zofran cause cerebral palsy? 

Zofran has been linked to congenital birth defects which have the ability to cause cerebral palsy. For additional information on Zofran use and cerebral palsy, refer to our article, Zofran and Cerebral Palsy.

The Future of Zofran and Birth Defects Claims

Although birth defects claims against Zofran are still relatively new, more and more studies are beginning to help prove the correlation between taking the medication and its hazardous risks to unborn infants.

While only a few birth defects lawsuits have been filed so far, the plaintiff in the aforementioned case may have set the path for many other mothers to come forward. If your infant was born with a birth defect associated with Zofran, you may be eligible for compensation for medical treatment, medications, pain, suffering, lost wages, and more.