Zofran Use During Pregnancy May
Be Responsible For Birth Defects

Zofran Birth Defect Lawsuits

There are serious potential pregnancy risks associated with the use of Zofran, an anti-nausea medication commonly prescribed to pregnant women for morning sickness, following reports that suggest some expectant mothers taking Zofran may have a greater risk of giving birth to children with developmental defects and serious congenital malformations possibly leading to infant death. If you took Zofran during pregnancy, and your child was born with cleft lip, cleft palate, spina bifida, or another severe birth defect, you may be entitled to financial compensation for your child’s injuries, medical expenses, and pain and suffering. Call us today or complete the form on this page for a completely free, no obligation case review.

Get Help Now Before It’s Too Late

The parents of children born with devastating birth defects allegedly caused by exposure to Zofran in utero may be able to pursue compensation from the maker of the morning sickness drug, for damages including past and future medical bills, future loss of earnings, and a diminished quality of life. Unfortunately, due to statute of limitation laws, you may only have limited time to file a claim. You and your family should not have to suffer as a result of the negligence of drug manufacturing companies like GlaxoSmithKline, a pharmaceutical giant that brought in $17.9 billion in profits in 2013 alone. Get the compensation you and your child deserve to get the necessary medical care to treat any potential injuries.

What is Zofran/What does it do?

Zofran (ondansetron), a pharmaceutical drug manufactured by GlaxoSmithKline, is a member of a class of drugs known as 5-HT3 receptor antagonists, which function by blocking the actions of serotonin, a chemical found in the body that contributes to nausea. Zofran was approved by the U.S. Food and Drug Administration (FDA) in 1991, for use among patients undergoing chemotherapy treatment or surgery who are struggling with nausea symptoms. However, the medication has also been widely prescribed off-label for pregnant women suffering from a severe form of morning sickness called hyperemesis gravidarum, despite the fact that it has never been approved for that use.

A very small percentage of pregnant women experience morning sickness severe enough to warrant a Zofran prescription, yet research shows that as many as one million pregnant women take Zofran or generic ondansetron every year. This is in spite of the fact that the FDA has never approved Zofran use among pregnant women, which means GlaxoSmithKline has never been required to show that the anti-nausea drug is safe and effective for this particular use. Still, recognizing a new market of patients for its anti-nausea medication, GlaxoSmithKline took it upon itself to begin advertising Zofran to expectant mothers looking for relief from severe bouts of morning sickness.

Learn more about the dangers of Zofran at Consumer Safety Watch

About GlaxoSmithKline

GlaxoSmithKline is a large pharmaceutical drug company known for its cutting-edge vaccines, its widely-used health products, and its global initiative to make medications more affordable in developing countries. However, the GSK name and its commitment to “enabling people to do more, feel better and live longer” has been tarnished in recent years, as a number of the company’s products have been linked to serious problems, most notably its Avandia diabetes drug, which was tied to an increased risk of heart attack, and was eventually banned in Europe and restricted in the United States. Zofran is currently one of GlaxoSmithKline’s best-selling drugs, yet this medication has also come under fire recently, and dozens of Zofran lawsuits have been filed in courts across the United States, on behalf of families whose children were born with severe birth defects after being exposed to the anti-nausea drug during pregnancy.

Potential Birth Defects Associated with Zofran

The FDA has classified Zofran as a pregnancy Category B medication, which means there are no adequate or well-controlled studies detailing the safety of Zofran use among expectant mothers. However, there are a growing number of studies that have examined the potential pregnancy risks of Zofran, and these studies suggest that the anti-nausea drug is capable of crossing the human placenta during pregnancy and causing harm to a developing fetus. According to research, women who take Zofran while pregnant may have an increased risk of giving birth to babies with the following birth defects:

  • Persistent pulmonary hypertension of the newborn (PPHN)
  • Spina bifida
  • Craniosynostosis
  • Cleft lip
  • Cleft palate
  • Club foot
  • Kidney malformations
  • Heart defects
  • Fetal growth restriction
  • Lung defects
  • Fetal death

Morning sickness is typically worst during the first trimester of pregnancy, and many mothers rely on Zofran and other anti-nausea drugs to get them through the first few weeks. Unfortunately, this is the time that developing babies are most susceptible to harm, and the time that neural tube defects and other devastating birth defects are most likely to occur.

Studies Linking Zofran to Birth Malformations

One of the earliest studies linking Zofran to an increased risk of birth defects in babies was published in the medical journal BJOG: an International Journal of Obstetrics and Gynaecology in September 2004. Researchers involved in the study highlighted case reports that linked Zofran use in pregnancy to a greater risk of hypospadias birth defects in babies, but this alleged connection between Zofran and genital malformations was never investigated by GlaxoSmithKline. Several years later, research published in the medical journal Birth Defects Research indicated that expectant mothers who took Zofran to treat their morning sickness faced a 2.4-times higher risk of giving birth to babies with cleft palate birth defects.

Several more Zofran birth defect studies have been published in recent years, one of the most significant being a New England Journal of Medicine study published in August 2013, which found that exposure to Zofran in utero increased a baby’s risk of birth defects by 30%, and doubled their risk of heart malformations. The following year, the journal Reproductive Toxicology published research indicating that women who used Zofran during the first trimester of pregnancy doubled their risk of giving birth to babies with atrial septal defects, ventricular septal defects, and other “hole in the heart” malformations. The researchers involved in the study also found a 62% increased risk of heart birth defects overall in babies exposed to Zofran in the womb.

In December 2014, Dr. Gideon Koren published the findings of his Zofran study in the American Journal of Obstetrics and Gynecology, concluding that babies whose mothers take Zofran while pregnant may face “a two-fold increased risk of cardiac malformations” and “an overall 30 percent increased risk of major congenital malformations.” While some of the birth defects allegedly linked to Zofran use in pregnancy are treatable, like cleft lip and cleft palate, others are not. Spina bifida, for example, has no cure, and is typically associated with a host of physical and neurological problems, infections in the tissue surrounding the brain (meningitis), and other complications, like learning disabilities, attention disorders, and problems with reading and language.

Zofran Birth Defect Warnings from the FDA

Given the growing body of research linking Zofran use by pregnant women to a host of devastating congenital malformations, it would make sense that federal regulators would ensure that consumers and medical professionals are aware of these risks. However, the FDA has yet to issue an official warning about the potential for Zofran use in pregnancy to cause serious birth defects in babies, and so it happens that a million or more pregnant women take Zofran or its generic equivalent every year as a treatment for morning sickness, unaware of the fact that the prescription medication may interfere with the development of their unborn baby.

Lawsuits Filed Over Zofran Birth Defects

Although there has been evidence of a potential link between Zofran use in pregnancy and birth defects in babies for years, this information is just now making its way to consumers and becoming public knowledge. As a result, parents across the country whose children were born with spina bifida, cleft lip, cleft palate and other major malformations, are filing legal claims against GlaxoSmithKline and pursuing compensation for their children’s injuries, costly medical bills, and emotional trauma. In August 2012, the U.S. Department of Justice filed a claim against GlaxoSmithKline, accusing the drug maker of illegally marketing Zofran off-label as a treatment for morning sickness, in violation of federal law, and GSK was ordered to pay $3 billion to resolve the claims.

While doctors are permitted to prescribe medications off-label to patients when they deem the treatment safe and effective, drug manufacturing companies like GlaxoSmithKline are prohibited from marketing their products for uses not approved by the FDA. Yet this is exactly what GSK is accused of doing, promoting Zofran as a treatment for expectant mothers suffering from severe pregnancy-related nausea, despite the fact that the medication has never been approved for morning sickness. In many cases, women who used Zofran while pregnant admitted that, had they known about the alleged pregnancy risks association with Zofran, they never would have taken the drug in the first place.

More than 60 Zofran lawsuits have already been brought against GlaxoSmithKline for alleged Zofran birth defects, and as families across the United States become aware of the potential for Zofran to interfere with fetal development and cause severe birth defects in babies, a growing number of Zofran claims are expected to be brought against GSK in the coming months. It is important that the parents of affected children seek professional help from an experienced Zofran birth defect lawyer before pursuing a product liability claim against GlaxoSmithKline, so they can ensure that their legal rights are protected and improve their chances of recovering the compensation their child deserves.

How an Experienced Zofran Attorney Can Help

Having a child born with severe birth defects can be devastating for everyone involved, and the medical bills associated with congenital malformations like spina bifida and persistent pulmonary hypertension of the newborn can be costly, especially if the defects require ongoing medical care. If your child was born with one or more birth defects, and you believe the anti-nausea medication Zofran to be the cause, an experienced birth defect lawyer can help. With a qualified Zofran attorney on your side, you may be able to file a product liability lawsuit against GlaxoSmithKline, in order to pursue the financial compensation your child deserves for his injuries. Fill out the form on this page, or call us today to speak to a reputable lawyer and discuss filing a Zofran claim against GlaxoSmithKline.

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