Cefotetan-induced haemolytic anaemia. A review of 85 cases.
OBJECTIVE
Reports of cefotetan-associated haemolytic anaemia have prompted a US Food and Drug Administration (FDA) review of the overall number, severity, and causality of such cases.


RESULTS
A search of the FDA's Spontaneous Reporting System and the World Health Organization's database revealed 85 cases of haemolytic anaemia since the approval of cefotetan in 1985, 15 of them fatal. Moderate to severe haemolysis was reflected in a mean fall in haemoglobin levels by 6.65 mg/dl (n = 20) and a mean final haemoglobin concentration of 5.2 mg/dl (n = 52). Transfusion of packed red blood cells was required in 47 patients (55.3%). New onset renal dysfunction was noted in 7 patients (8.2%). The direct antiglobulin test was positive in 50 patients (59%), and serological studies revealed antibodies to cefotetan in 30 patients (35%).


CONCLUSIONS
These data suggest that treatment with cefotetan may induce severe autoimmune haemolytic anaemia.
University of California at Irvine Medical Center/Miller Children's Hospital, 2685 Elm Avenue, Long Beach, California 90806, USA. rvirarag@uci.edu
Roopa
R
Viraraghavan
Aloka G
AG
Chakravarty
Janice
J
Soreth
D058186:Acute Kidney Injury / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000744:Anemia, Hemolytic, Autoimmune / Q000139:chemically induced* / Q000453:epidemiology / Q000401:mortality; D015313:Cefotetan / Q000009:adverse effects*; D002511:Cephalosporins / Q000009:adverse effects; D002513:Cephamycins / Q000009:adverse effects*; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006461:Hemolysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D013997:Time Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D014944:World Health Organization
D002511:Cephalosporins; D002513:Cephamycins; D006454:Hemoglobins; D015313:Cefotetan