This is Michael Brady Lynch, lead trial attorney at The Michael Brady Lynch Firm.
Today, the FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran. Zofran may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. Patients at particular risk for developing Torsade de Pointes include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.
Zofran it is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. The FDA is requiring GlaxoSmithKline (GSK) to conduct a thorough QT study to determine the degree to which Zofran may cause QT interval prolongation.
I am encouraged that the FDA has acted on the side effects of Zofran and that GSK will be required to conduct future safety studies. Nausea is a serious issue with cancer patients, obviously, but there are safe alternatives on the market. There is no need to expose Americans suffering from cancer to additional risks and hardship.
About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects such as Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, as well as Actos Bladder Cancer and Fosamax Femur Fractures, and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.
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