2010-04-08
In January, the U.S. Food and
Drug Administration (FDA) issued a warning to health-care professionals that cases of intravascular
hemolysis (IVH) and its complications, including fatalities, have been reported
in patients treated for immune thrombocytopenic purpura (ITP) with WinRho
SDF. IVH can lead to clinically compromising anemia and multi-system
organ failure including acute respiratory distress syndrome. Serious
complications have been reported including severe anemia, acute renal insufficiency, renal failure,
and disseminated intravascular coagulation. Fatal
outcomes associated with IVH and its complications have occurred most
frequently in patients of advanced age (age over 65) with co-morbid conditions.
The Box Warning informs health-care professionals that:
- Patients should be closely monitored in a health-care setting
for at least eight hours after administration.
- A dipstick urinalysis should be performed at baseline, two
hours, four hours after administration, and prior to the end of the monitoring
period.
- Patients should be alerted to and monitored for signs and
symptoms of IVH, including back pain, shaking chills, fever, and
discolored urine or hematuria. Absence of these signs and/or symptoms of
IVH within eight hours do not indicate IVH cannot occur subsequently.
- If signs and/or symptoms of IVH are present or if IVH is
suspected after WinRho administration, post-treatment laboratory tests
should be performed including plasma hemoglobin, urinalysis, haptoglobin,
LDH (lactate dehydrogenase), and plasma bilirubin (direct and indirect).
For additional information about the warning, visit the FDA Drug Safety Information Web site.
Since the release of the warning, ASH has heard from
hematologists who have questions and concerns about how they will get
reimbursed for the increased observation time when using WinRho for
Medicare patients. Many physicians may have seen reimbursement guidance
from the manufacturer, but the specific codes the companies suggest using are
not recognized by Medicare. ASH is exploring alternative
codes to use for the extended observation, but has not yet identified another
option. The Society will continue to investigate how this drug will be
reimbursed and will keep members informed as more information becomes
available.
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