Zofran Side Effects
ATTENTION, WOMEN WHO HAVE USED THE DRUG ZOFRAN DURING PREGNANCY
Zofran used during pregnancy for morning sickness or nausea has been linked to serious birth defects in children. If you or a loved one took Zofran while pregnant, you and your child may be entitled to financial compensation.
ZOFRAN BIRTH DEFECTS
Our law firm has been investigating the link between Zofran taken for morning sickness during the first trimester of pregnancy and serious fetal injuries. We believe there is now strong evidence that Zofran (ondansetron) may be the cause of these defects.
Birth defects may include:
- Cleft lip
- Cleft palate
- A congenital heart defect (atrial septal defect, ventricular septal defect, heart murmurs)
Zofran Birth Defects Research
A Safety Communication was issued by the FDA in September 2011 stating that the 32mg dose of Zofran may “increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.”
How to get help
Call us today at 800-280-0070 or complete our online form to get a free consultation and learn more about your rights.
The manufacturer of Zofran, GlaxoSmithKline, conducted an FDA-ordered trial to study those risks through January 2012. Shortly thereafter, the FDA issued another Drug Safety Communication which stated that preliminary results showed:
- Electrocardiogram (ECG) changes including QT interval prolongation
- Torsade de Pointes, or an abnormal and potentially fatal heart rhythm
- Elevated risk in patients with congenital long QT syndrome
- Congestive heart failure
- Or those who were taking additional medications that have been known to cause QT interval prolongation
Healthcare practitioners were warned by the FDA not to use the 32 mg dose of Zofran. Zofran was ultimately recalled.
ZOFRAN RECALL AND HISTORY
The FDA has asked brand name and generic drug manufacturers to recall their version of GlaxoSmithKline’s 32 mg dose of Zofran (ondansetron).
In 1991, the FDA approved Zofran to treat chemotherapy-related nausea and later expanded that approval to treat PONV, or postoperative nausea and vomiting. Many pregnant women were prescribed Zofran to alleviate severe nausea symptoms.
- Drug Use: Approved to treat nausea and vomiting in chemotherapy and surgery patients
- Manufacturer: GlaxoSmithKline
- Injury: Heart malformations, cleft lip, and cleft palate birth defects in the children of pregnant women who have been prescribed Zofran for nausea.