Zofran (ondansetron) may increase the risk of certain heart problems, according to the U.S. Food and Drug Administration (FDA):
Ondansetron 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.
The manufacturer is GlaxoSmithKline LLC (GSK). In 2012, GSK agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from, among other things, the company’s unlawful promotion of certain prescription drugs, including Zofran:
It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.
If you took Zofran during your pregnancy for morning sickness and your baby was born with heart problems or another birth defect, your child may have a personal injury claim against GSK, and possibly others. There is a limited time to file a lawsuit. This is called the statute of limitations, and it is longer for children. You can click here now for a free consultation and ask our lawyers about this.
In addition to possible cardiac problems, ondansetron, an active ingredient in Zofran, may cause cleft lip and cleft palate, according to some medical research. You can read more about Zofran and cleft lip and palate here.
Torsade de Pointes
The possible changes in the electrical activity of the heart include prolongation of the QT interval of the electrocardiogram (ECG). According to the FDA, this can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes.
Torsade de Pointes is an abnormal heart rhythm that makes the heart unstable. There can be a sudden drop in blood pressure, causing dizziness and fainting. In some cases, it can lead to ventricular fibrillation, which can lead to death.