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SafetyAlerts
January 10, 1999

4 Deaths Prompt Warning of Adverse Events Associated with WinRho* Immune Globulin Intravenous

Washington DC (SafetyAlerts) Cangene Corporation and NabiĀ® have issued a warning letter to healthcare professionals and the Food and Drug Administration (FDA) warning of possible adverse events following administration of WinRho* Immune Globulin Intravenous.

Between April 1996 and April 1999, 15 cases that involved the acute onset of IVH following treatment of D-positive ITP patients with WinRho* were reported to the Food and Drug Administration (FDA).  An additional 26 cases of possible IVH in ITP patients treated with WinRho were reported to FDA between May and October 1999 and are being further evaluated.

The 15 cases included four patients who died, one of whom died from complications secondary to IVH-induced exacerbation of anemia. Although the primary cause of death in the other three patients was related to underlying disease, the extent to which IVH-related clinical complications exacerbated their conditions and contributed to their deaths is unknown.

Other clinical complications in the 15 patients included onset or exacerbation of anemia in seven patients (six of whom received packed red blood cells) and acute onset or exacerbation of renal insufficiency in eight patients (two of whom underwent dialysis). Six patients experienced more than one IVH-related complication.

The current WinRho SDF™ package insert references the occurrence of IVH under the Adverse Reactions/Treatment of ITP section, therefore, other sections of the labeling for the product will be modified to include all of the above information. This information can be found in the attached addendum.

Healthcare professionals should report serious adverse events possibly associated with the use of WinRho to Nabi at 1-800-327-7106. Alternatively, this information may be reported to FDA's MedWatch reporting system by phone (1-800-FDA-1088), facsimile (1-800-FDA-0178), the MedWatch website at www.fda.gov/medwatch, or mailed to MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787, using Form 3500, which is available from any of the above FDA listings.

 
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