Other neurologic toxicities included somnolence, lethargy, and confusion. Cytologic abnormalities characterized by giant, hyperchromatic nuclei reported in lymph nodes, pancreas, thyroid, adrenal glands, liver, lungs, and bone marrow. Dysplasia may be sufficiently severe to cause difficult interpretation of exfoliative cytologic examinations of the lungs, bladder, breast, and uterine cervix. Four cases of acute leukemia occurred among 19 patients who became pancytopenic in a 243-patient study that included busulfan adjuvant therapy following surgery for bronchogenic cancer. Clinical appearance of leukemia seen 5-8 years after oral busulfan treatment.
Drug is a presumed human carcinogen.
Five of 61 patients given drug in clinical trials were over 55 years of age, and all achieved myeloablation and engraftment. Sterility, azoospermia, and testicular atrophy seen in male patients. Drug may cause fetal harm when given to pregnant women. The solvent, DMA, also may cause fetal harm. Studies are being done to define pharmacokinetics in children.