Can Zofran Cause a Birth Defect or Birth Injury?

Zofran Birth Injury Lawyers Fighting for the Rights of Children and Families

Photo of infant care due to birth defectMost women who have been pregnant will tell you that suffering through morning sickness can be a far more serious issue than many people realize. In fact, in some cases, the dehydration, vomiting and weight loss associated with morning sickness can become so relentless and severe that it requires hospitalization and medication to treat. One medication that has been prescribed to treat morning sickness in pregnant women is Zofran.

Zofran is an anti-nausea medication approved by the US Food and Drug Administration (FDA) for patients undergoing surgery and cancer patients receiving chemotherapy treatments. The drug decreases vomiting and nausea by blocking serotonin and increasing gastric emptying. Although the FDA has not approved Zofran to be taken by pregnant women, it has been prescribed by some doctors “off-label” to women suffering severe morning sickness. 

Is It Dangerous to Take Zofran If I’m Pregnant? 

Multiple studies have shown that taking Zofran while pregnant might cause a birth defect or birth injury. The results of an Australian study published in December 2013 showed that taking Zofran during the first trimester of pregnancy led to an increased risk of birth defects of 20 percent.

In addition, in 2014, a study that was based on Swedish Medical Birth Register records showed that women who took Zofran during the first trimester of their pregnancy doubled the risk of a child developing a cleft palate. That same study also revealed that taking Zofran during the first trimester increased an unborn child’s risk of developing a serious heart defect.

What Risks Can My Child Face If I Take Zofran While Pregnant?

If the risk of children suffering heart defects and cleft palates was not serious enough, Zofran has been associated with additional birth injuries and defects, including but not limited to:

  • “Hole in the heart” defects
    • Atrial septal defects
    • Ventricular septal defects
    • Atrioventricular septal defects
  • Kidney malformations
  • Cleft lip and palate
  • Developmental delays 

Why Would My Doctor Prescribe Zofran If It’s Not Safe? 

The manufacturer of Zofran allegedly has convinced doctors that the drug is safe for pregnant women for off-label purposes, including morning sickness. Therefore, the main responsibility for these birth injuries lie with pharmaceutical giant GlaxoSmithKline (GSK). As legal proceedings unfold, some of the claims raised against GSK have included allegations that the drug maker bribed doctors with money, kickbacks and gifts to get them to prescribe Zofran. 

Zofran Research and Case Updates 

Over the past few years, litigation involving Zofran-related birth injuries has seemingly ramped up, with news concerning the drug and its victims getting to the point that it makes headlines on a regular basis:

  • July 2012 – GSK reached a $3 billion settlement concerning several allegations, including claims that it illegally marketed Zofran for unapproved use.
  • August 2013 – Danish researchers found that taking Zofran during the first trimester of pregnancy raised the chances of giving birth to a child with severe birth defects 20 percent.
  • December 2014 – An investigation by the Toronto Star revealed that Zofran could be causing deformities and other birth defects.
  • January 2015 – After being given Zofran, two children died of heart problems, according to a Pediatric Emergency Care study.
  • February 2015 – A Minnesota mother filed a birth injury lawsuit concerning pregnancies in 2004 and 2006. She was prescribed Zofran during both pregnancies, which resulted in each her children being born with serious heart defects. Another suit was filed in Massachusetts over multiple congenital heart abnormalities suffered by a child whose mother took Zofran while she was pregnant.
  • March 2015 – A 2-year-old girl whose mother was prescribed Zofran while pregnant with her has to undergo major heart surgery because of issues related to her heart being twice as big as normal and having two holes in it.
  • April 2015 – The parents of a 16-year-old in Montana who has had to undergo 10 surgeries in an attempt to correct her cleft palate filed a birth injury lawsuit against GSK, according to KVVU-TV. In the suit, the parents claim that Zofran caused her cleft palate. 

How Can a Zofran Birth Injury Lawsuit Help Victims? 

The devastation that a birth defect or birth injury can have on the life of a child and the family he or she is born into is incalculable. These injuries are often something that the child will have to live with for the rest of his or her life. In addition, birth injuries and defects like the kind that might result from taking Zofran are many times catastrophic. Such injuries can require a lifetime of round-the-clock medical care, which is extremely costly and greatly lowers the quality of life of the child and his or her family.

No amount of money is going to make up for what was taken from birth injury victims and their families. However, a birth injury lawsuit can help families hold corporations responsible for harm and prevent the same thing from happening to more families. In addition, lawsuits can help victims secure the money they need to cover the cost of healthcare, modifications to their homes and vehicles, education and rehabilitation associated with the birth injury. 

Find Me a Zofran Birth Injury Lawyer 

If you or someone you love was given Zofran while pregnant and have a child who is suffering with a birth defect because of it, the birth injury lawyers at Farrell & Patel want to help you. Our attorneys are dedicated to helping injury victims and their families. We are especially passionate about protecting children, as evidenced by our work helping the children of Miami Children’s Hospital.

For more information about Farrell & Patel, check out the successful case results our firm has secured for clients or testimonials from people we have helped in cases. To have one of our lawyers review your case for free, do not hesitate to call us directly at (305) 300-3000, fill out the case review form on this page or visit our firm’s contact page.