Recent studies have linked use of the anti-nausea drug Zofran (generic: ondansetron) by pregnant women to heart murmurs and other congenital birth defects. A heart murmur is an abnormal sound such as whooshing or swishing made by turbulent blood flow in and around the heart.
Free Zofran Heart Murmur Lawsuit Evaluation: If your child or other loved one was born with a heart murmur after the mother took Zofran (ondansetron) while pregnant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Zofran and we can help.
Zofran has been approved by the U.S. Food & Drug Administration (FDA) for the prevention of nausea and vomiting associated with surgery or cancer medications. The drug works by blocking serotonin, a neurotransmitter in the body that enables brain cells and other nervous system cells to communicate with one another. Zofran is classified as a serotonin 5-HT3 receptor antagonist, or antiemetic, meaning that it is designed to block nausea and vomiting.
What’s the Problem?
Zofran is not approved to treat the symptoms of morning sickness, but it has been prescribed “off-label” for this purpose. It is legal for doctors to prescribe drugs off-label; however, the safety of Zofran for treating morning sickness has not been established.
According to the American Hospital Formulary Service Drug Information, “there are no adequate and controlled studies to date using ondansetron in pregnant women, and the drug should be used during pregnancy only when clearly needed.”
Canada’s regulatory authority, Health Canada, has discouraged use of Zofran in expecting mothers and warned physicians that “the safety of ondansetron for use in human pregnancy has not been established.”
Zofran Birth Defect Studies
- In 2002, a study conducted by the Centers for Disease Control and Prevention (CDC) and Sloan Epidemiology Center at Boston University found that Zofran use during the 1st trimester of pregnancy doubles the risk of cleft palate in newborns.
- A 2006 Hong Kong-based study confirmed that Zofran crosses the human placenta during the 1st trimester, and was detected in every sample of fetal tissue taken among 41 patients.
- Another study whose cohort included all women who had children in Denmark between 1997 and 2010 (903,207 births) found the risk for major coronary artery abnormalities like heart murmurs doubled with the use of Zofran to treat morning sickness during the 1st trimester.
What is a Heart Murmur?
Normal heartbeats make a “lub-dupp” or “lub-dub” sound. This is the sound of the heart valves closing as blood moves through the organ. A heart murmur is an unusual whooshing or swishing sound heard during a heartbeat. Depending on the severity of the defect, the sound of the murmur may range from faint to very loud.
Signs and symptoms of a heart murmur in a newborn baby may include:
- Rapid breathing
- Difficulty feeding
- Blueness in the lips (cyanosis)
- Failure to thrive
Symptoms in older patients may include:
- Difficulty exercising or doing physical activity
- Chest pain
To assess whether a heart murmur is normal (“innocent”) or something more serious, a doctor will check the child’s pulse and blood pressure, and listen to his or her heart with a stethoscope. The doctor will then attempt to determine where in the heart the murmur is coming from, when in the heartbeat cycle it occurs, how loud it is and whether it changes when the child moves.
If the murmur is determined to be abnormal or “non-innocent,” it may be caused by a congenital heart defect such as a leaking valve, narrow artery or hole in the heart. If a problem is found, treatment may include drugs to regulate the heart’s rhythm or surgery to correct a structural defect. Many congenital defects are minor and don’t require treatment, as they do not affect the heart’s function.
Can I File a Zofran Heart Murmur Lawsuit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against GlaxoSmithKline (GSK), the maker of Zofran, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of Zofran, our attorneys suspect that patients may be able to take legal action in light of claims that Zofran failed to adequately warn doctors and patients about the risk of heart murmurs.
How Can Filing a Lawsuit Help Me?
By filing a lawsuit against the maker of Zofran, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your child’s heart murmur, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.
Do I Have a Zofran Heart Murmur Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently accepting new heart murmur cases in all 50 states.
Free Zofran Heart Murmur Lawsuit Evaluation: Again, if your child or other loved one was born with a heart murmur after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a Zofran Suit and we can help.