December 21, 1999
AstraZeneca Warns of Serious Adverse
Effects During Off-Label Use of Streptase
Wilmington, DE (SafetyAlerts)
- AstraZeneca has today released a letter to warn physicians and hospital pharmacies of
the occurrence of serious adverse events associated with an off-label use of
Under postmarketing surveillance, AstraZeneca has
received an increasing number of reports of adverse events associated with the use of
STREPTASE to restore patency of intravenous catheters (including central venous
catheters). The serious adverse events include hypotension, hypersensitivity reactions,
apnea, and bleeding, some of which were life threatening.
While the events themselves are not inconsistent
with those currently listed in the approved labeling, they represent an increase in
frequency and appear to follow the reduced availability of Abbokinaseâ (urokinase).
STREPTASE is not indicated for
restoration of patency of intravenous catheters. Most of the serious adverse events
relating to the use of streptokinase in the restoration of patency of occluded intravenous
catheters reported to AstraZeneca have involved the use of high doses of streptokinase in
small volumes (250,000 IU in 2 mL). Uses of lower doses of streptokinase in infusions over
several hours, generally into partially occluded catheters, or local instillation into the
catheter lumen and subsequent aspiration, have been described in the medical literature.
The company is warning Health care
providers to consider the risk for potentially life-threatening reactions associated with
the use of streptokinase in the management of occluded intravenous catheters.
Adverse events possibly associated with the use of
Streptase should be reported to the Information Center at AstraZeneca at 1-800-236-9933.
Alternatively, this information may be reported to
FDAs 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.
Both health care professionals and consumers
should use the Form 3500 for reporting adverse events.
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