A safety review of temozolomide identified cases of aplastic anemia, some fatal, associated with use of the drug. Healthcare professionals should be alert to the possibility of aplastic anemia in the setting of refractory or prolonged myelosuppression in patients receiving temozolomide and report cases to FDA's MedWatch.
From August 11, 1999, to November 3, 2006, FDA received 18 (domestic-14, foreign-4) reports of aplastic anemia among patients receiving temozolomide. Product labeling currently includes a warning regarding myelosuppression and describes pancytopenia among reported adverse events.
Source: http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#Temozolomide
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