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The national lawsuit alleges that the manufacturer of Zofran knew of this severe side effect, but failed to properly inform the United States government and healthcare providers that Zofran could cause significant potential issues, and that the drug required additional testing and research before it should have been widely marketed and prescribed to patients who had better alternative treatments.
Zofran is the brand name for a prescription medication known as ondansetron hydrochloride. It is classified as a serotonin 5-HT3 receptor antagonist. Serotonin is a type of neurotransmitter, a chemical produced in the brain that relays information between nerve cells. Serotonin is found primarily in the lower gastrointestinal tract, where it plays a role in the movements of the intestines. The 5-HT3 receptor is the specific protein molecule that receives serotonin signals. When this particular receptor is activated by a substance (such as alcohol), it can cause nausea and vomiting as well as anxiety, and in some cases, increase the likelihood of seizures.
Zofran, which has been available in generic form since 2006, may be taken orally or by injection.
Commonly reported side effects of Zofran include headaches and dizziness, as well as constipation. A few patients have reported damage to the inner ear as well, though these have not been confirmed. The medication has also been associated with a potentially fatal form of arrhythmia (irregular heartbeat), known as torsades de pointes. Patients should avoid operating machinery while taking Zofran, as it may impair cognitive function and reaction time.
A number of articles have been published in medical journals, presenting evidence that suggests a link between the use of Zofran by pregnant women and birth defects. Although the issue is still being debated and studied, the general consensus among medical professionals is that Zofran should not be considered as a treatment for morning sickness unless all other treatments have failed. It has been established that Zofran can be transferred to the fetus through the placenta up to twelve weeks after conception.
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