Also known as Ondansetron, Zofran is a medication used to prevent nausea and vomiting caused by serious medical conditions including the chemotherapy and radiation therapy used to treat cancer, as well as for those who have undergone surgery. The drug made the World Health Organization’s List of Essential Medicines, which identifies the most important medications needed in basic health systems.
Zofran is a serotonin receptor antagonist and works by blocking the actions of chemicals in the body whose function it is to trigger nausea and vomiting.
The most common side effects associated with this drug include:
While some side effects may be normal, others can be abnormal and result in severe health risks. These include but are not limited to:
These side effects are severe and can pose a serious health risk.
Serotonin syndrome/toxicity – While the brain needs serotonin to function, excessive levels can have serious consequences. The potentially deadly symptoms of this condition include confusion, changes in blood pressure, rapid heart rate, loss of muscle coordination, and more. Severe cases of this syndrome can result in death and is especially dangerous for patients who exhibit high fever, seizures, and unconsciousness.
Birth defects – While many expectant mothers can experience nausea and vomiting, Zofran should not be used to treat it. However, it has been, and in many cases, has been linked to birth defects when the child is born. Several studies have suggested this is especially true when the drug is taken by the mother during the first trimester. Parents have also complained that the drug has given their children cleft lip, cleft palate, and other congenital malformations.
Especially in the cases of birth mothers and children born with defects after being exposed to the drug in utero, the number of cases against the drug and its maker GlaxoSmithKline has grown to over 300, although the number is expected to go into the thousands once the public is made aware of its dangers. The suits allege that Glaxo hid data showing that Zofran was linked to serious birth defects and failed to warn the public. Patients also accuse the maker of improperly marketing Zofran as a safe treatment for morning sickness without FDA approval.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.