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FDA Medwatch Alert: Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms
Posted 15 Sep 2011 by Drugs.com
ISSUE: FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics). Ondansetron 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. BACKGROUND: Zofran (ondansetron) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. FDA is ... Read more
Related support groups: Zofran, Ondansetron, Zofran ODT, Zuplenz
FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film
Posted 7 Jul 2010 by Drugs.com
WOODCLIFF LAKE, N.J., July 2 /PRNewswire/ – Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication. The FDA approval was granted based on clinical study data comparing the bioequivalence of Zuplenz 8 mg to Zofran ODT (orally dissolving tablet) 8 mg. The pharmacokinetic results of these studies demonstrated that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT. "The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment ... Read more
Related support groups: Ondansetron, Nausea/Vomiting -- Chemotherapy Induced, Nausea/Vomiting -- Postoperative, Nausea/Vomiting -- Radiation Induced
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Related Condition Support Groups
Nausea/Vomiting, Nausea/Vomiting -- Chemotherapy Induced, Nausea/Vomiting -- Postoperative, Alcohol Dependence, Gastroenteritis, Obsessive Compulsive Disorder, Nausea/Vomiting -- Radiation Induced, Postanesthetic Shivering, Pruritus