Pharmacy Services
Tipranavir (Aptivus) Associated With Intracranial Hemorrhage
July 6, 2006
Boehringer Ingelheim is updating the product labeling for tipranavir (Aptivus). The company identified 14 cases of intracranial hemorrhage (ICH) in 13 out of 6,840 patients receiving combination HIV therapy. Eight of these events were fatal, and many patients had concomitant medical conditions that may have contributed to the ICH events. The mean time of onset of these events was 525 days. Routine coagulation parameter monitoring is not recommended as tipranavir is not known to alter coagulation parameters. The company recommends using tipranavir with caution in patients at increased risk of bleeding.
More information can be obtained online at the following web sites:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150415.htm - Letter to Healthcare Professionals:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM153070.pdf - Revised Product Labeling:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf
Updated
July 6, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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