Zofran Birth Defects Lawsuits
Morning sickness is a common occurrence for pregnant women. Most pregnant women experience nausea while only about a third experience vomiting. Morning sickness begins early in pregnancy and can last until weeks 14 – 16, although some women have morning sickness throughout their entire pregnancy.
Morning sickness may be caused by a fluctuation in hormones, but its exact cause is unknown. Zofran (Ondansetron) is a prescription drug used to prevent nausea and vomiting caused by cancer chemotherapy, radiation treatment, and surgery. It is also prescribed to treat morning sickness in pregnant women. Typically, Zofran is prescribed after trials of other morning sickness treatments have failed. Women who have taken Zofran during pregnancy may place themselves and their child at an increased risk of birth defects.
If you or your child has suffered a Zofran birth defect or other injury, contact a Zofran lawyer to discuss your right to reimbursement for your harms and losses. For a FREE confidential evaluation of your Zofran claim, call 855-552-2337.
The anti-nausea drug Zofran, generically known as Ondansetron, is in a class of drugs called serotonin 5-HT3 receptor antagonists. These drugs are used to prevent nausea and vomiting in cancer patients.
Zofran FDA Warnings
Zofran was developed in the mid-1980’s by the pharmaceutical company GlaxoSmithKline in London. The drug was patented in the US in 1987 and was approved by the FDA in 1991. By the time its patent protection expired in 2006, Zofran had become the 20th highest-selling brand-name drug in the United States.
Although the FDA approved the drug for use with cancer patients, it did not approve Zofran as a treatment for morning sickness in pregnant women, and the drug’s increase in use for this purpose has recently come under scrutiny.
In November 2013, the FDA issued a warning not to use Zofran during pregnancy. The FDA came to this decision based on recent studies that showed an association between the use of Zofran in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate). Further, there are risks to pregnant women with electrolyte imbalance due to vomiting. More specifically, risks include Serotonin Syndrome that can cause symptoms such as confusion, agitation, autonomic instability, and neuromuscular changes.
Does Zofran Cause Birth Defects?
In August 2013, a group of Danish researchers took data gathered during a previous study on Ondansetron and incidents of birth defects. They examined over 900,000 patients over a thirteen-year period (1997 – 2010). Their results detected a twofold increase in congenital heart defects associated with Ondansetron usage during the first trimester.
Another study (9,000 pregnant women) performed by the Center for Birth Defects Research and Prevention identified a twofold risk increase for cleft palate associated with Ondansetron usage during the first trimester. If your child has suffered from any of the following Zofran birth defects, you may be entitled to compensation:
- Congenital Heart Defects – A congenital heart defect is a problem with the structure of the heart. The defects can involve the walls and valves of the heart and the arteries and veins near the heart. The defects can cause the blood flow to the heart to slow down, flow in the wrong direction or be blocked completely. Signs of congenital heart defects include rapid breathing, fatigue, poor blood circulation, and cyanosis.
- Cardiac Arrhythmia – The heartbeat is too fast, too slow, or irregular.
- Serotonin Syndrome – Occurs when the body reacts negatively to two drugs taken together. The drugs cause too much serotonin to be released or to remain in the brain area. Symptoms can occur within minutes to hours and include: agitation, diarrhea, fast heartbeat and high blood pressure, hallucinations, nausea, vomiting, and loss of coordination.
- Cleft Palate - When the skull fails to properly form in the roof of the mouth.
- Cleft Lip – Defect in the upper lip of an infant.
- Club Foot – Occurs when an infant’s foot muscles, joints and bone develop.
Zofran Precautions and Side Effects
Do not stop taking your medications, such as Zofran, until you speak with your doctor. If you are taking Zofran and are experiencing any of the following side effects, consult your doctor immediately:
- blurred vision or temporary vision loss (lasting from only a few minutes to several hours);
- severe dizziness, feeling short of breath, fainting, fast or pounding heartbeats;
- slow heart rate, trouble breathing;
- anxiety, agitation, shivering;
- feeling like you might pass out; or
- urinating less than usual or not at all.
Less serious side effects may include:
- diarrhea or constipation;
- weakness or tired feeling;
- headache; or
- dizziness, drowsiness.
This is not intended to be a complete list of side effects, and you should immediately contact your doctor if you are having any other problems.
Zofran Birth Defect Lawyer
In 2012, GlazoSmithKline pled guilty in federal court to charges of fraud and illegal promotion of several drugs, including Zofran, and paid $3 billion to settle.
In February 2015, a mother, claiming her use of Zofran during pregnancy caused her daughter severe birth defects, filed a lawsuit against GloxoSmithKline. Like many other expectant mothers, she used Zofran to curb her morning sickness, which was affecting her performance at work. Her daughter was born with congenital heart defects, hearing loss, webbed toes, low set ears, and facial dysmorphia. Her daughter has had ten surgeries in 12 years to correct these abnormalities.
If you took Zofran while pregnant and your child suffered a birth defect or other side effect, contact a St. Louis Zofran lawyer to discuss your case at 855-552-2337. We are help to help Zofran users across all 50 states. All consultations are free and there is no fee unless we win. Call 24 hours a day, 7 days a week to discuss your case with Top 100 Trial Lawyer.