Xigris Side Effects Lawsuit
Xigros, a drotrecogin alfa drug, is used for the intravenous treatment of sepsis. This drug is a recombinant form of human activated protein C and is supplied as preservative-free, lyophilized, sterile, white to off-white powder for intravenous infusion. The vials are 5 to 20 mg and contain 5.3mg and 20.8mg of drotrecogin alfa (activated). The vials also contain 40.3 and 158.1 mg of sodium chloride, 10.9 and 42.9 mg of sodium citrate, and 31.8 and 124.9 mg of sucrose.
Drotrecogin alfa (activated) is a serine protease with the same amino acid sequence as human plasma-derived activated protein C and is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Human plasma-derived activated protein C and Drotrecogin alfa (activated) have the same sites of glycosylation, although some differences in the glycosylation structures exist
Xigris Side Effects Lawsuit
Xigris® is indicated for the reduction of mortality in adult patients with severe sepsis by decreases inflammation and the formation of blood clots in blood vessels and also increasing the breakdown of blood clots. It should be intravenously administered at a 24mcg/kg/hr, based on actual body weight, for a total of 96 hours. Xigris should be restarted at 24mcg/kg/hr if the infusion is interrupted. The drug should be administered using a dedicated intravenous line or a dedicated lumen of a multilumen venous catheter and exposure to heat and direct sunlight should be avoided.
There is no known antidote for Xigris so in the event of an overdose, immediately stop the infusion and monitor closely for hemorrhagic complications.
Xigris increases the risk of bleeding so it should not be used in situations where bleeding can cause significant morbidity or death such as active internal bleeding, recent (within 3 months) hemorrhagic stroke, recent (within 2 months) intracranial or intraspinal surgery, or severe head trauma, trauma with an increased risk of life-threatening bleeding, in the presence of an epidural catheter, or intracranial neoplasm or mass lesion or evidence of cerebral herniation.
Sepsis is a severe medical condition that causes a whole-body inflammatory state called systemic inflammatory response syndrome (SIRS) and is characterized by the presence of a known or suspected infection. After common illnesses such as pneumonia and bacterial infections Sepsis can develop. Sepsis is also known as blood poisoning and causes approximately 1400 deaths every day worldwide.
It is not yet completly understood what the specific pharmacologic effects by which Xigris exerts its effect on survival in patients with severe sepsis are. Xigris infusions of 48 or 96 hours produced dose-dependent declines in D-dimer and IL-6 in patients with severe sepsis.
Xigris was the subject of a FDA safety review earlier this year because of a study showed Xigris, when used by patients with a recent history of hemorrhages, increased the risk of dangerous internal bleeding.
The most commonly reported adverse reaction is bleeding in patients receiving Xigris therapy.
Patients and patients' caregivers should be informed of the potential benefits and risks associated with Xigris by their healthcare provider, including the most common side effect, bleeding.