"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"...
In postmarketing experience there have been a limited number of medication error reports of excessive rate of Xigris (drotrecogin alfa) infusion for short periods of time (median 2 hours). No unexpected adverse events were observed during the overdose period. However, this information is insufficient to assess whether Xigris (drotrecogin alfa) overdose is associated with an increased hemorrhage risk beyond that observed with Xigris (drotrecogin alfa) administered at the recommended dose.
Xigris (drotrecogin alfa) increases the risk of bleeding. Xigris (drotrecogin alfa) is contraindicated in the following clinical situations where bleeding could lead to significant morbidity or death:
- 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
- Presence of an epidural catheter
- Intracranial neoplasm or mass lesion or evidence of cerebral herniation
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
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.