Does Zofran Cause Birth Defects?

Birth defects can happen for a variety of reasons, some of which are unknown. There are certain behaviors, actions during labor and delivery, and even medications that can increase someone’s risk of giving birth to a baby with serious medical conditions. This can be a difficult situation for any parent, but it’s much harder when the mother or parents knew nothing of the risks and now must help their child adjust to life with a serious birth defect. 

Up to 4 percent of all babies are born with some kind of birth defect. It’s defined as a physical abnormality or a health problem. In the most difficult scenarios, the birth defect is severe enough that the baby only lives for a few months. Doctors might also refer to birth defects as “congenital abnormalities.” 

Certain conditions are more common than others when it comes to all birth defects. The most common ones are cleft lip/palate, heart defects, spina bifida, and Down syndrome. When a baby is diagnosed with one of these, it can mean expensive treatments and years of impact for the child and the family. 
 
When a family member can show that a child's birth defect was caused by medical malpractice or a defective drug, this can become the basis of a personal injury lawsuit. 

Between the sixth and ninth weeks of pregnancy, the roof of the mouth is formed. During this critical time, cleft palate symptoms can begin for a baby. Children who have this often struggle with feeding or speaking as a result. For some babies, only part of the palate will be open, while others will have both the front and back parts of the palate open. 

There are multiple studies that indicate a connection between Zofran pregnancy birth defects. In one recent case, the makers of Zofran, GlaxoSmithKline, pled guilty to criminal fraud and settled with the United States Department of Justice for over $3 billion in fines due to illegal marketing of Zofran and other drugs. One study found that Zofran was connected to a 237% risk of cleft palate defects. Another study identified that it doubled the risk of heart defects in newly born babies and increased the overall risk of birth defects by 30%.

Unfortunately, many women unknowingly expose their unborn children to birth defects while taking Zofran throughout pregnancy, and a growing number of personal injury lawsuits claim that the manufacturer of the drug failed to warn about these side effects and has continued to avoid providing any warnings to pregnant women about Zofran and birth defects. 

Originally approved in 1991 for the treatment of vomiting and nausea caused by radiation therapy, surgery, and chemotherapy, Zofran is popularly given to pregnant women today. Generic versions have been available since 2006. However, Zofran was never approved or even submitted to the FDA for use by pregnant women to control their morning sickness. It has been classified by the FDA as pregnancy category B, meaning that it is untested for safety. And no human trials or studies have been completed to show that it is safe for pregnant women, meaning that it's used is off-label.

Currently, no dosage is approved as safe for pregnancy, meaning that pregnant women face a risk of side effects, including birth defects, by taking this medication. The marketing of this medication off-label led to the 2012 $3 billion settlement with the Department of Justice. In that lawsuit, GlaxoSmithKline was accused of marketing off-label Zofran used for morning sickness and failing to update their label to warn pregnant women about the possible risks.

More parents are just now learning about the link between Zofran and birth defects. 

Birth defects connected to the use of Zofran while pregnant include cleft palate defects, atrial ventricular septal defects, AVSD, kidney obstruction birth defects, overall birth defects, atrial septal defects, ventricular septal defects, and congenital heart defects. The dangers of Zofran for use within a pregnancy are especially remarkable given the higher risk for septal birth defects. The study found that those women who use Zofran in their first trimester when women are most likely to report nausea and vomiting to their doctor were 210% more likely to develop atrial septal defects and 480% more likely to have atrial ventricular septal defects.

One study looked at data from the National Birth Defects Prevention Study and mothers with expected delivery dates between September 1997 and December 2004. Zofran usage during the first trimester was connected with a 237% higher risk of cleft palate birth defects. And that means that women who use Zofran throughout their pregnancy give birth to children with cleft palates at more than double the rate.

Zofran is a serotonin blocker. Zofran is approved for vomiting and nausea in chemo patients and for those who are recovering from surgery only. It is available in multiple doses and forms, including an oral solution, a tablet, an injectable, and orally disintegrating tablets. None of those forms of Zofran, however, have been submitted to the FDA for safety testing on pregnant women.

Given that so many women suffer the impacts of nausea and vomiting during the early days of their pregnancy, many doctors have turned to prescribing this medication as a way of relieving these uncomfortable symptoms. When the woman is focused on the impact of the day today's nausea, however, she might not know the long-range impact of taking this medication and how it can increase her child's chances of having birth defects. No parent intends to partake in activities that could increase the chances of birth defects, which makes it all the more devastating to realize after the fact that the parents and doctors should have been warned about this dangerous connection. 

Children who suffer birth defects don’t just deal with these consequences immediately after their birth; they also have to cope with them throughout their lifetime. They might need additional support in their formative years to hit developmental milestones and can even struggle psychologically as they begin to notice they are different from their peers. 

As a parent, it can be very difficult to watch the challenges that your child is facing due to a birth defect. This is compounded when you know that the birth defect could have been prevented. Many mothers who took this medication might even have guilt about using it to deal with their pregnancy side effects. It is important to remember that if you were not informed about the possible risks of this drug, you could be eligible to hold the manufacturer of the drug accountable for these side effects and long-lasting birth defects.

If you believe that your child developed birth defects, because you were given Zofran during your pregnancy, you could be eligible to open a lawsuit with a birth defects lawyer. A birth defects attorney can help you to navigate this process and to help you prepare a claim for compensation. Given that birth defects, including cleft palate and congenital birth defects, can have significant costs for treatment and can have a lifelong impact on your child, you need to get the support of an experienced birth injury lawyer as soon as possible.

When drug manufacturers are accused of making or marketing medications that carry significant side effects about which users were not warned, this can lead to lawsuits. Retaining an experienced attorney is essential for fighting back against these pharmaceutical companies. When many families have had to suffer the consequences of serious birth defects, many of these individuals will band together in a class-action lawsuit against the responsible party. 

Despite clinical trials for the on-label uses, there are limited or no studies available when a medication is used off-label. This means that it is often the case that users of the drugs must come forward and shed light on these dangerous situations. While your family will be forever impacted by the diagnosis of a birth defect associated with a medication, you might be able to prevent other families from going through this similar situation. Furthermore, contacting an experienced lawyer could be the first step towards recovering damages that could help pay for your child's medical bills and allow your family to move forward into a new chapter. 

You can fill out a simple contact form in under a minute, and receive a free, no-obligation case evaluation from the experts at Morgan & Morgan to get started.