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Cancer patients undergoing chemotherapy treatments and radiation therapy often suffer acute nausea and vomiting due to the large amount of chemicals being taken in by the body. For many patients, this nausea is unbearable and adds to their suffering during the cancer treatment process. For this reason, doctors prescribe certain medications to prevent and treat nausea and vomiting after chemotherapy. One of these prescribed medications is Zofran.
Zofran, or ondansetron, works by blocking serotonin, the natural substance in the body that induces nausea and vomiting. Zofran is given to chemotherapy and radiation patients, as well as patients coming out of surgery. Many patients have benefitted from Zofran during tough chemotherapy sessions, but others have suffered from negative and lifelong effects after taking the drug.
The FDA has cited abnormal heart rhythms in association with the use of Zofran, which can cause the larger problem known as Torsade de Pointes, or “twisting of the points.” This is an abnormal heart rhythm that has been known to cause sudden cardiac death. The FDA believes Zofran may change the electrical activity (known as QT interval prolongation) of the heart, which in turn causes harmful abnormal heart rhythms.
Patients with a personal or family history of heart conditions are at greater risk of developing abnormal heart rhythm due to taking Zofran, as are those predisposed to low blood magnesium and potassium or other QT syndromes.
The other, more minor adverse side effects associated with taking Zofran include diarrhea, fever, drowsiness, headache, dizziness, muscle spasms, blurred vision, and rash. Zofran should not be taken during pregnancy or while nursing, as the potential for it to be excreted in breast milk and to cause birth defects is still being investigated.
The most dangerous effects of Zofran, however, have not been related to the heart – they’ve been due to its being marketed to pregnant women without FDA approval, resulting in serious birth defects.
While the FDA approved Zofran for use by chemotherapy and radiation patients, it was never approved for use by pregnant women. Despite this fact, the Zofran manufacturer (GlaxoSmithKline) marketed the drug to pregnant women to reduce morning sickness. They offered a similar drug, called Zuplenz, for the same reason. Sadly, recent studies have linked Zofran to birth defects in pregnant women, most likely because the drug passes through the placenta.
After women who had taken Zofran issued dozens of birth defect complaints, Glaxo plead guilty to federal charges in 2012. They were found guilty of:
The Glaxo lawsuit was the largest settlement by a drug company in history, amounting to more than $3 billion in charges. It provided proof to the general population that the FDA will hold drug companies accountable for their actions and won’t allow healthcare fraud.
Women who used Zofran are still filing lawsuits against Glaxo, since they took the drug without being informed about the unreasonable risk of harm associated with it for pregnant women. Glaxo knew about these health risks, yet continued to market the drug and other generic versions of it to women for morning sickness.
Due to Glaxo’s gross negligence, women everywhere are still suffering from harmful abnormal side effects and toxicity from Zofran and its generic versions, as well as devastating birth defects such as:
Statistics show that over one million women are still taking Zofran or its generic counterparts today, unaware of its potential hazards. Understanding the great risk of taking these drugs for morning sickness can save women and children everywhere from undergoing traumatic effects. The attorneys at Sweeney Merrigan Law are sensitive to your plight if the problems connected with Zofran have affected your life, and offer a free consultation to discuss your case in detail. Contact us at (617)-391-9001.