The Food and Drug Administration (FDA) has ordered manufacturer GlaxoSmithKline (GSK) to expand the warning section of the labels for the popular drug Zofran (ondansetron, ondansetron hydrochloride and their generics). The drug, which is used to combat nausea and vomiting from chemotherapy, was shown in a study to carry an increased risk of Torsades de Pointes, a potentially life-threatening heart arrhythmia. According to Reuters, the update removes the 32mg single intravenous dose, but states that the drug can continue to be used at the lower recommended intravenous dose of 16mg.
Manufacturer GlaxoSmithKline recently plead guilty to multiple charges of marketing multiple drugs for unapproved uses, giving financial benefits to doctors as a marketing strategy, and making improper claims about the safety of these drugs.
The FDA had voiced concern in September over the potential adverse effects the drug could have on the heart, and ordered GlaxoSmithKline to conduct further research. It was found in a clinical study that the high dosage of intravenous Zofran could affect the electrical activity of the heart (QT prolongation), leading to the potentially-fatal condition of Torsades de Pointes. The FDA warned that patients with congestive heart failure, congenital long QT syndrome, bradyarrhythmias, and those taking concomitant medications were the most at risk of the irregular heart rhythm.
Manufacturer GlaxoSmithKline recently plead guilty to multiple charges of marketing multiple drugs for unapproved uses, giving financial benefits to doctors as a marketing strategy, and making improper claims about the safety of these drugs. The nine prescription drugs covered by the settlement included Advair, Wellbutrin, Paxil, Lamictal, Zofran, Imitrex, Lotronex, Flovent and Valtrex. Zofran, specifically, was allegedly approved only for post-operative nausea, but it was promoted by GSK to treat morning sickness in pregnant women.
Have you experienced an irregular rhythm while taking Zofran? If so, you may be able to participate in a defective drug lawsuit seeking compensation for your injuries. To find out if you may have a case, simply fill out the free case review form on the right. Our attorneys are extremely experienced in providing advocacy to those that have been injured as a result of dangerous drugs, and are currently reviewing claims concerning Zofran today.