Birth Defects: Zofran and Ondansetron

Did You Take Zofran for Morning Sickness?

The safety risks of Zofran are being investigated thoroughly and various agencies are monitoring all developments. If you or a loved one took Zofran for morning sickness during pregnancy and if your baby was born with a cleft palate, cleft lip, or congenital heart defect, please contact us by calling us at for a confidential evaluation of your potential claim.

What is Zofran?

Zofran and generic versions of ondansetron have been approved by the United States Food and Drug Administration to prevent nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. It is in a class of drugs known as 5-HT3 receptor antagonists that work by blocking the action of serotonin, a natural chemical produced by the human body that can cause nausea and vomiting. However, it is not now, nor has ever been, approved to treat morning sickness at any stage of a pregnancy.

Risks for Babies

The safety of Zofran for treating morning sickness has not yet been established. The FDA has not yet found it to be a safe or effective for treatment of nausea and vomiting during pregnancy. According to the official federal compendium American Hospital Formulary Service Drug Information, “there are no adequate and controlled studies to date using ondansetron in pregnant women, and the drug should be used during pregnancy only when clearly needed.” Health Canada, Canada’s regulatory authority, has required a warning to physicians that “the safety of ondansetron for use in human pregnancy has not been established” and “the use of ondansetron in pregnancy is not recommended.”

A U.S. Centers of Disease Control and Prevention and the Sloan Epidemiology Center at Boston University conducted in 2012, has reported that taking ondansetron in the first trimester of pregnancy can double the risk of cleft palate in newborns. This study analyzed data from 9,000 women and included information from the National Birth Defects Prevention Study. Another study conducted in Denmark between 1997 and 2010 which included all births during that period (903,207 births) found the risk for major congenital heart defects also doubled with use of Zofran to treat nausea and vomiting during the first trimester. In addition a study conducted in 2006 of forty-one patients in Hong Kong, showed Zofran readily crosses the human placenta in the first trimester of pregnancy and was detected in every sample of fetal tissue.


Pharmaceutical giant GlaxoSmithKline (GSK) developed ondansetron (originally marketed under the brand name Zofran) the mid-1980s. London-based GSK is one of the top ten pharmaceutical companies in the world in terms of sales.

The FDA first approved Zofran in 1991. Its only approved uses are for chemotherapy, radiation therapy, and post-operative related nausea and vomiting. GSK’s patent expired in 2006. The FDA approved the first generic versions of ondansetron the same year. GSK continued to market and sell Zofran even after generics became available.

In 2006—the final year of GSK’s patent protection on the drug—Zofran ranked number 20 in brand name drug sales in the U.S. with sales of $1.3 billion in the first 9 months of 2006 (80% from the U.S.). Some of these blockbuster sales resulted from prescriptions to pregnant women for morning sickness—again, a use not approved by the FDA.

Between 1983 and 2013, no drug was approved for use to treat morning sickness. The drug Bendectin (pyridoxine/doxylamine) had been removed from the market in 1983, but the pyridoxine / doxylamine combination continued on the market under different brand names in Canada and elsewhere for the next thirty years. Doctors then began prescribing drugs off-label—most commonly, Zofran—for the non-approved use of alleviating pregnancy-related nausea and vomiting.

After years of studies, the FDA approved the return of the combination of pyridoxine and doxylamine under the new brand name Diclegis in 2013. Even after the approval of Diclegis for morning sickness, approximately one million women last year were still prescribed Zofran or a generic equivalent of ondansetron.

What Does This Mean for You?

If you had a baby born with a cleft palate, cleft lip, or congenital heart defect after taking Zofran for morning sickness during your first trimester of pregnancy, you and your child may be legally entitled to compensation for pain and suffering, medical costs, loss of income, emotional distress and other damages.

You are an Individual and so is Your Claim

If, after reviewing your unique situation with our attorneys, you decide to move forward with a lawsuit, please know that your case will remain your own individual case. Your Zofran lawsuit is not a class action. Instead, our lawyers will file a suit based on your particular circumstances and any damages awarded will be based solely on your experience.

Zofran Birth Defects

Zofran Birth Defects in Birmingham, ALZofran is an anti-nausea drug that is often prescribed to pregnant women in Birmingham, Alabama to combat morning sickness. At first considered to be safe for pregnant women and their babies, recent evidence shows that the drug may cause birth defects in babies born to women who took Zofran during pregnancy. About a million women per year take Zofran for morning sickness.

GlaxoSmithKline manufactures Zofran, also sold under its generic name ondansetron. Despite the prevalent view among doctors that Zofran was safe for pregnant women suffering from morning sickness, a 2014 study published by the American Journal of Obstetrics and Gynecology found that other studies of the drug couldn’t rule out Zofran as posing a risk to the fetus of a woman taking the drug. Additionally, a 2013 study found that use of Zofran during pregnancy doubled the risk of cardiac malformations in the fetus of Danish women taking the drug.

Very little is known about the safety of Zofran for the fetuses of pregnant women taking the drug, but based on the evidence available now, it’s likely that the risks aren’t fully disclosed yet.

Zofran works by blocking chemicals that cause nausea in the body. Its intended use is to prevent vomiting and nausea caused by chemotherapy drugs and radiation therapy. As previously mentioned, the drug is also used to treat morning sickness in pregnant women.

Zofran, or Ondansetron, is classified as “pregnancy category B” by the Federal Drug Administration (FDA), meaning that “Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.” Some possible birth defects that may result from taking this drug are:

  • Atrial septal defect (ASD)
  • Ventricular septal defect (VSD)
  • Tetralogy of fallot (TOF)
  • Club foot
  • Transposition of the great arteries
  • Developmental delays
  • And more

Drug manufacturers are required by the law to make sure their drugs are safe. Although they are required to go through a complex approval process by the FDA, that does not guarantee that the approved drugs are safe. The sometimes flawed FDA approval process combined with the drug companies’ profit motive makes for a dangerous situation for the public.

Can I sue for my child’s birth defects if I took Zofran while I was pregnant?

Drug manufacturers can be held liable under Alabama (and other U.S. state law) called “products liability.” Products liability cases come in three standard varieties:

  1. Design Defect cases are cases where the drug maker could have foreseen that the product was dangerous to consumers due to the way it was designed. In these cases, if the manufacturer could have avoided the injuries by changing the way the product was manufactured, they are responsible.
  2. Marketing Defect cases are cases where the manufacturer could have, but did not, give adequate warning about foreseeable risks presented by the product (including drugs).
  3. Manufacturing Defect cases are cases where the marketing and design of the product aren’t problematic, but a problem during the manufacturing process results in a defect.

A lawsuit may claim that one or more of these types of defects caused the Plaintiff’s injuries.

Who can be sued?

Although a negligent drug manufacturer is often the responsible party when a drug injures a person, others also may be held liable. A pharmacist or pharmacy can be held liable if the pharmacist offered the plaintiff advice about the drug that resulted in the plaintiff’s injuries. As indicated earlier, a doctor also may be liable for prescribing the wrong drug, failing to notify the injured person of potential side effects. Hospitals also may be held liable for drug injuries. Testing laboratories also can be held liable for their negligence in drug defect cases.

Which of these potential defendants should be sued in a drug birth defect case is a very complex question requiring the assistance of an experienced Birmingham, Alabama Zofran birth defect attorney.

Do drug manufacturers have any defenses to a Zofran products liability case?

Yes. Some products are deemed “unavoidably unsafe.” These products cannot be made safe for “their intended or ordinary use.” These unavoidably unsafe products are often given a pass by courts. It’s paramount that a drug manufacturer does not prevail in its argument that a drug is unavoidably unsafe. A knowledgeable Jefferson County drug lawsuit attorney may be able to overcome this argument by the drug manufacturers.

What if my doctor was at fault?

Often, drug manufacturers who are sued by injured consumers or their families argue that the injury was caused by medical malpractice by a doctor and not by the drug manufacturer. A drug manufacturer who prevails in a claim like this may not be held liable or may be held only partially liable for the Plaintiff’s injuries. Your physician may be held liable in addition to the drug manufacturer if the drug was improperly prescribed or you were improperly warned about its potential side effects.

How long do I have to file my Zofran birth defect case?

Under Alabama law, you have two years to file a Zofran birth defect case, although when that 2-year period begins and when it may be extended is a very complex question requiring experience with these types of cases. (Ala. Code § 6-2-2 et seq.)

Taking Prescription Drugs during Pregnancy

Even in the best and healthiest pregnancies, vigilance is required in how prescription and over-the-counter drugs will affect the mother’s health and the viability of the unborn child. Medical treatment, such as prescription drugs like Zofran, is one subject that receives well-deserved scrutiny from critics. From in the scientific community to government regulatory bodies to anecdotal evidence, people need the most updated information about what is safe (and unsafe) to take during pregnancy.   After all, whatever a pregnant woman affects the health and well-being of her developing baby.

Under the supervision of a medical professional, a pregnant woman can find relief for some of the more extreme examples of pregnancy-related side effects. Some of these physical effects include severe nausea, vomiting, and dizziness lasting beyond the first trimester. In some cases, the mother’s own physical health is threatened, like when the difficult condition hyperemesis gravidarum is diagnosed.

When the body’s inability to retain fluids and maintain hydration is compromised, there is little that can be done to relieve the condition that will not also threaten the safety of the fetus. This presents the quandary of balancing the pros and cons of ingesting over-the-counter or prescription drugs. For many women, the discomfort just comes with the territory and the risks outweigh any potential benefits. For others who experience intense nausea and vomiting, but do not require hospitalization, taking drugs like Zofran to manage the distress seems like an imperfect, yet necessary trade off.

If you or a loved one believes that Zofran may have caused a birth defect, keep in mind:  average citizens are not in the business, regulatory or commercially, to make decisions regarding food and drug safety. Doctors accept the responsibility with licensure. Depending on any warnings that were omitted or should have been given prior to a patient consenting to take Zofran, doctors may bear some responsibility in any resulting damage. The fact that the drug manufacturer, GlaxoSmithKline, advertised Zofran for nausea relief during pregnancy, that company may share some responsibility.

Zofran remains a controversial prescription drug for use during pregnancy. Lauderdale County families deserve the best chances for the health and well-being that is medically and ethically possible. The conflict between relief from intense morning sickness and possible harm to an unborn baby makes many women wary of choosing Zofran. Families should know they have rights, beyond having chosen to use Zofran for an off-label use. If you have questions about your rights or birth defects resulting from Zofran or other prescription drugs taken during pregnancy, please do not hesitate to reach out to one of our caring and experienced attorneys.