Following a recently concluded clinical study, the U.S. Food and Drug Administration has announced an update on the possible dangers of the drug Zofran, used to prevent nausea and vomiting caused by surgery, chemotherapy or radiation treatments to treat cancer.
Zofran, also known as ondansetron, previously came under federal scrutiny when it was found that some patients taking a 32 mg intravenous dose experienced changes in the electrical activity of their hearts. Such a change could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.
GlaxoSmithKline markets Zofran and has said it will change the drug label to remove the 32 mg single intravenous dose. The drug will still be used to treat adults and children with nauseating effects from cancer treatments, but a lower recommend dose of 0.15 mg/kg every four hours for three doses. A single intravenous dose should not exceed 16 mg due to the risk of changes in the heart’s electrical activity caused by the medicine.
FDA’s Warnings on Zofran
The FDA’s new information does not change the recommended oral doses of Zofran to counter chemotherapy induced vomiting and nausea. The FDA recommends that patients should discuss any concerns they may have about ondansetron with their healthcare professional, and warns that anyone taking the medicine who experiences an irregular heartbeat, shortness of breath, dizziness, or fainting should seek immediate care. The organization also asks ondansetron patients to report any side effects to the FDA via its website, www.fda.gov.
Those who have experienced problems from Zofran may want to consult an attorney to pursue their legal rights to obtain compensation for any harm or damages they have suffered.