As studies connect the use of the anti-nausea drug Zofran in pregnant women to birth defects, including cleft lips, heart defects, cleft palate and other serious conditions, Nevada Zofran lawsuit attorneys allege that drug maker GlaxoSmithKline promoted the drug for treating morning sickness—a purpose not approved by the U.S. Food and Drug Administration (FDA). Lawsuits also claim that the drug maker neglected to disclose risks of the birth defects for pregnant women who used the drug.
If you took Zofran during pregnancy and your child has birth defects, contact Attorney Group for Nevada for more information about the options available to you. At no out-of-pocket cost to you, we can help answer your questions in a confidential, no obligation consultation. If you have a case, we can connect you with an affiliated Zofran lawsuit attorney in Nevada or another state who can assist you throughout the legal process.
What is Zofran?
Zofran, the trade name for Ondansetron, is a medication produced by GlaxoSmithKline and is FDA approved as a treatment for vomiting and anti-nausea in surgery, chemotherapy and radiation therapy patients. It can also prevent the normal complication of shaking in people who have had anesthesia. However, as of March 2015, the FDA has not been approved it for treatment of morning sickness, although many doctors prescribe the drug “off label” for that purpose.
How Does Zofran Work?
Zofran is in a class of drugs known as serotonin 5-HT3 receptor antagonists that block the neurotransmitter serotonin. Nearly 80 percent of the body’s serotonin is found in the gastrointestinal tract, and it induces vomiting and nausea by acting on the receptors in the stomach and brain stem. Zofran inhibits serotonin from making this interaction, suppressing nausea and vomiting.
Risk of Injury
The FDA has not approved the use of Zofran for pregnancy-related morning sickness. Studies suggest that use during pregnancy can double the risk of heart defects, and increase the overall risk of birth defects in pregnant women who take Zofran by 30 percent. Other studies show that using Zofran during pregnancy also boosts the risk of cardiovascular defects significantly.
Risks of Zofran
The most prevalent types of birth defects that Zofran can potentially cause include musculoskeletal irregularities, mouth disfigurements, jaundice and heart defects. Specific birth defects have been linked to the use of Zofran during pregnancy, including:
- Heart murmur
- Cleft lip
- Atrial septal defect
- Heart defects
- Kidney defect
- Cleft palate
- Ventricular septal defect
- Fetal growth restriction
- Hole in the heart
- And more
Other known side effects of Zofran include diarrhea and constipation, drowsiness or a tired feeling and a headache. Hives or a rash, chills, fever, difficulty breathing and swelling in the face, lips tongue or throat may also follow use of the medication, and may be signs of an allergic reaction.
Other Zofran Side Effects
Other side effects of the medication are far more serious. Additional inherent risks to the mother have also been connected to Zofran use during pregnancy, particularly those who suffer from an electrolyte imbalance as a result of excessive vomiting and nausea. Serotonin Syndrome is among the possible Zofran side effects, which can produce multiple behavioral and cognitive changes including neuromuscular changes, autonomic instability, confusion and agitation. Children who take Zofran are also at risk. Deaths of children under the age of 16 who used Zofran were examined in a 2006 FDA report. The report listed cardiac arrhythmias, bradycardia, palpitations and syncope among known adverse reactions.
Affected families are encouraged to seek legal counsel from a Zofran attorney in Nevada to learn more about their legal rights and remedies.
Contact Us For More Information
If you or a loved one took Zofran during pregnancy and delivered a child with birth defects, contact Attorney Group for Nevada for more information. You can fill out the form on this page, call us at the number listed at the top of the page, or email us at [email protected].
When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim for an injury. If you think you have a case, you should not delay taking action.
See our Frequently Asked Questions page for more information, and contact Attorney Group for Nevada today.