Zofran Lawsuit- An Overview
Brand name and generic drug producers have asked by the FDA to recall from the marketplace their edition of Zofran 32mg dose. Zofran was approved by the FDA in early 1991 as being fit for treating chemotherapy-associated nausea and later extended the approval to include treatment of postoperative nausea and vomiting (PONV)
In September 2011, the FDA released a Drug Safety Communication stating that the Zofran 32mg dose "amplify the danger of growing irregular changes in the electrical motion of the heart, which has the capability of resulting in a deadly irregular heartbeat." An FDA conducted test was then undertaken by the drug manufacturer GlaxoSmithKline, which lasted until early 2012 in an attempt to ascertain the existence of the presumed dangers. After about six months later, the FDA released yet another Drug Safety Communication stating that the initial results proved:
ECG or electrocardiogram changes together with QT interval prolongation.
Torsades de Pointes, or an unusual and possibly dangerous heartbeat is several patients.
Heightened danger in patients suffering from bradyarrhythmias, congestive heart failure, congenital long QT disorder or patients taking additional prescription known to cause QT interval prolongation.
Thus, the FDA cautioned medical practitioners against using the 32 mg dose because of Zofran cleft lip issues. Later on, in December of the same year, the FDA released another Drug Safety Communication announcing the Zofran recall. It is advisable for a patient to seek immediate medical attention in case they experience faintness, dizziness, irregular heartbeat, or shortness of breath while undertaking Zofran treatment.
While Zofran 32 mg dose was initially approved by the FDA to be used by cancer patients suffering from surgery related nausea and patients experiencing vomiting as a chemotherapy side effect, the drug manufacturer soon found other users for it-expectant women experiencing morning sickness.
The challenge is, Zofran 32 mg dose was not approved by the FDA for use in pregnant women. Numerous studies that were carried out regarding Zofran 32 mg dose in expectant women, indicates that, usage of the drug resulted what has become popularly known as Zofran birth defects and a twofold increased risk of cleft palate. When the cases involving health complications associated with "off-label" usage of Zofran 32 mg dose increased, the U.S Department of Justice filed a suit against the drug manufacturer. Click here to hire the best lawyers to help you with this lawsuit.
Finally, the manufacturer of Zofran 32 mg dose, GlaxoSmithKline agreed to pay 3 billion dollars in settlement, making history for being the largest health care fraud settlement in America. Zofran 32 mg manufacturer, GklaxoSmithKline, pleaded guilty to three counts of criminal charge and paid 1 billion dollars for the same. The other 2 billion dollars went to settle civil liabilities with the federal government and particular states.
