January 10, 1999
4 Deaths Prompt Warning of Adverse Events
WinRho* Immune Globulin Intravenous
Washington DC (SafetyAlerts) Cangene Corporation and
Nabi® 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
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.
Safety Alerts compiles comprehensive safety recall information for
the United States. SafeMail is a free email service to warn consumers of faulty products
and contaminated foods. For complete information regarding current recalls, past recalls
and timely product warning notification visit: www.safetyalerts.com.
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