Charleston Zofran Defective Drug Lawyer
Pregnant women have a lot of things to cope with while pregnant. One of those things may well be nausea and vomiting. In fact, an estimated 50 percent of women suffer from some form of morning sickness during their first trimester.
Although it is relatively common and there have been other drugs in the past that helped pregnant women cope with morning sickness, we now have a new generation of nausea pills, Zofran (ondansetron), and its generic forms, approved by the Food and Drug Administration (FDA) in 1991.
Zofran is a Category B drug and has not been shown to be safe for use in pregnant women. So why is this drug and its generic forms being prescribed?
You may know the name Zofran and may have taken it. It is one of the most common and widely prescribed anti-nausea medications on the market. The problem is that no one told patients and medical personnel about the serious side effects.
GlaxoSmithKline (GSK), Zofran’s maker and marketer, advertised/marketed the drug as “off label” for use by pregnant women. GlaxoSmithKline did so knowing that Zofran was not meant for long-term use.
A 2011 study reported that Zofran doubled the risks of birth defects, but the drug was still promoted to pregnant women. The study, published in the American Journal of Obstetrics and Gynecology, pointed out that roughly 1 million pregnant women are exposed to Zofran or its generic version every year. Side effects for pregnant women can include itching, constipation, fainting, irregular heartbeat, hives, dizziness and rashes.
In 2012, the Center for National Birth Defects Research and Prevention revealed that the chances of babies of mothers who used Zofran, in the first trimester, of developing a cleft lip and cleft palate increased 2.4 times over women who did not take the drug.
That same year, GSK also pleaded guilty to criminal charges relating to its off-label promotion of the drug. The company ended up paying a $3 billion settlement for unlawfully promoting several drugs, as well as Zofran, and for reimbursing physicians for prescribing the drug.
Zofran risks and side effects
Zofran has a history of being used intravenously, orally, via injections, or a fast disintegrating pill, for vomiting and nausea for chemotherapy/radiation patients and for postoperative nausea and vomiting. The drug blocks the body’s production of serotonin which causes nausea. Zofran is meant to be prescribed for short-term use by cancer patients and not for a long period of time, like in the case of morning sickness.
Studies indicate Zofran has been linked to a 30 percent increased risk of birth defects, and a doubled risk of various heart defects and cleft palate in children. Other risks include:
- Malformed kidneys
- Cleft palate
- Cleft lip
- Skeletal defects
- Skeletal abnormalities
- Skeletal disfigurement
- Heart defects
- Holes in the heart
- Septal defects
- Cranial defects
- Muscoskeletal deformities
- Abnormalities in the electrical function of the heart
- Serotonin syndrome
Serotonin syndrome is a serious, potentially life-threatening disease in expecting mothers that happens when two or more prescription drugs affect the natural serotonin levels in the body at the same time. Zofran combined with a class of antidepressants referred to as serotonin reuptake inhibitors (SSRIs) can cause serotonin syndrome. Symptoms of serotonin syndrome may include:
- Irregular heartbeat
- Behavior changes
- Heavy sweating
Plaintiffs’ allegations in Zofran lawsuits
Plaintiffs in Zofran lawsuits may make several allegations, such as the following:
- GSK unethically promoted the drug to pregnant mothers but did not conduct any studies on the effects of the drug.
- That by not conducting safety studies, pregnant women and their babies in utero became test subjects for the drug.
- GSK marketed Zofran off-label as a safe, effective treatment for morning sickness when the main use for the drug was for treating vomiting after cancer chemotherapy and prevent/treat nausea and vomiting post-surgery.
- That GSK was aware of animal studies that indicated Zofran caused malformations and intrauterine death, and it was not safe for ingestion by pregnant women.
- That GSK knew about the birth defect issue due to reports of such defects being sent to GSK in the 1990s and 2000s.
Talk to a lawyer
Have you experienced serious complications from taking Zofran? Seek an experienced Zofran attorney from the Steinberg Law Firm. Contact an attorney as soon as you can, as each state has its own statute of limitations and other deadlines that may affect your ability to obtain compensation if you wait.
The Steinberg Law Firm understands what it takes to make a strong defective product case that results in fair and equitable compensation for you. Call us today for your free consultation and learn about your legal rights. Call The Steinberg Law Firm at 843-720-2800 as soon as possible. We are waiting to hear from you.
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