"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Xigris (drotrecogin alfa) is administered in the intensive care unit, and in this setting, patients may be unresponsive or may have difficulty comprehending counseling information.
Patients and patients' caregivers should be informed by their healthcare provider of the potential benefits and risks associated with Xigris (drotrecogin alfa) , including the most common side effect, bleeding. Patients with clinical conditions likely to increase the risk of bleeding should be carefully evaluated and anticipated benefits weighed against potential risks associated with Xigris therapy [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS].
Last reviewed on RxList: 9/1/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Xigris Information
Report Problems to the Food and Drug Administration
Find out what women really need.