Zofran is a popular anti-nausea drug originally designed to help chemotherapy patients who were struggling with vomiting or nausea after undergoing their treatments or surgery. In recent years, however, this medication has become a popular one to give pregnant women suffering with nausea. The problem with this is that Zofran was never approved as being safe for this particular purpose. Patients may be under the impression that this drug is safe but new academic and medical studies show that it might put both mother and child in harm’s way. Those patients who have been affected may have grounds to file a lawsuit with the help of a Zofran lawyer.
The anti-nausea drug Zofran is frequently prescribed for pregnant women who are suffering the side effect of nausea. Unfortunately, recent studies have indicated that there is a 30% higher risk of birth defects and a double risk of hole in the heart defects in addition to high rates of cleft palate and cleft lip.
In the event that you have been injured after taking Zofran or if you have recently given birth to a child who suffered a birth defect after you took Zofran while pregnant, you may be entitled to recover compensation. Seeger Weiss LLP is currently taking cases in all fifty states. If you know someone who took Zofran during pregnancy and had a baby with a birth defect, you need to contact an attorney immediately for more information.
Unapproved Zofran Use
Zofran has been on the market since 1991 and it was originally prescribed to treat nausea associated with chemotherapy. However, the scope of this medication’s use has recently been expanded in order to incorporate nausea as a result of many other causes as well. Several different recent studies have been conducted in order to determine the potential risks of taking Zofran while pregnant.
The U.S. Food and Drug Administration originally approved Zofran only to assist cancer patients suffering from nausea after surgery or chemotherapy treatments. In 2006, doctors started prescribing the new generic versions of this medication since the manufacturer lost its patent.
In 2012, GlaxoSmithKline please guilty to charges at the federal level for fraud and illegal marketing of multiple drugs, one of which was Zofran. The company paid $3 billion as a part of a legal settlement. However, the manufacturer is headed back to defend other allegations about Zofran and other medications.
Zofran Presents Risks to Pregnant Women and Their Children
Court filings indicate that GlaxoSmithKline may have known as soon as 1992 that Zofran presented serious risk of harm to developing babies since the drug passes through the human placenta. Even with this knowledge, the drug maker continued to market the drug to pregnant women. This is why increasing numbers of patients and their family members are filing lawsuits with the help of a Zofran attorney. Some of the allegations include:
- The fact that Glaxo allegedly did not warn doctors and members of the public about dangerous side effects.
- Glaxo allegedly failed to properly evaluate all safety and data information regarding use of Zofran in pregnant women.
- Glaxo misrepresented the outcome of animal studies indicating that the drug was safe when instead the study results indicated signs of toxicity and abnormal bone growth.
One 2011 study identified that Zofran doubled the chances of a baby being born with a cleft palate. Despite this, the FDA has not stopped Zofran from being prescribed for off label use and doctors are still eligible to prescribe the drug to pregnant women. The FDA has issued additional warnings associated with heart complications in users. In 2011 the FDA issued a drug safety communication that the dosage of 32 mg could lead to serious issues.
Zofran has risks not just for the fetus, but also for the mother. Recent studies have linked this medication with higher risks of cognitive and behavioral changes in expectant mothers. Some of the symptoms experienced by women affected include:
- Autonomic instability
- Neuromuscular changes
Research Studies Highlight Dangers of Taking Zofran While Pregnant
One 2013 study in the New England Journal of Medicine identified data from Denmark and did not find an association between Zofran and birth defects, although other studies have disputed these results. For example, another 2013 study used the same data out of Denmark and found double the risk of heart defects and a 30% higher risk of birth defects overall for women who took Zofran while pregnant.
More than 1248 women took Zofran during their first trimester and 4.7% of them had a child with one or more birth defects compared with 3.5% of women who did not take Zofran. Zofran has also been linked to higher rates of heart defects, cleft palate and kidney defects.
Some of the most common birth defects associated with Zofran include:
- Heart murmur
- Heart defects
- Cleft lip
- Cleft palate
- Hole in the heart
- Muscular skeletal defect
- Fetal growth restriction
Has your child been a victim because you took Zofran while pregnant? Filing a lawsuit immediately may be the best way to protect his or her future. A child with birth defects may need special medical attention many years into the future.
You may be entitled to receive compensation if you or someone you know has taken Zofran and sustained critical injuries. Do not hesitate to reach out to an experienced attorney as soon as possible to discuss your rights.
Do I Have Grounds for a Zofran Lawsuit?
If you believe you may have been injured, you need an experienced legal team. With experienced attorneys in locations throughout the U.S., the firm strives to provide the highest quality of service to clients. Each case is treated with confidence and compassion. Do not hesitate to reach out to our law firm today to learn more about protecting yourself if you have been injured after taking Zofran. No iteration of Zofran is currently approved for use with pregnant patients.
Lawsuits against manufacturer GlaxoSmithKline call the company out for marketing Zofran to doctors and expectant mothers. The drug has racked up millions of dollars for GlaxoSmithKline in terms of profits, and there are approximately one million women taking this medication each year. If you have been injured or if you’ve recently given birth to a baby with birth defects you need to consult with an attorney as soon as possible regarding a Zofran lawsuit.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.