Intellipharmaceutics International Inc. (IPCI)

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Rexista's Blue Dye #1 is no laughing matter.










New England Journal of Medicine


http://www.nejm.org/doi/full/10.1056/NEJM200010053431416#t=article


Systemic Absorption of Food Dye in Patients with Sepsis
N Engl J Med 2000; 343:1047-1048
October 5, 2000

A 12-month-old boy with trisomy 21 underwent tracheostomy for obstructive apnea. Pseudomonas pneumonia with sepsis developed; aspiration was believed to have occurred. Blue dye no. 1 was added to his enteral feedings. He remained hemodynamically stable, with normal renal function, until the next day, when his skin, serum, and urine became blue and hyperthermia developed (rectal temperature, 47°C). He died of refractory hypotension and acidosis that day.

Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro4 and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro.5 It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).

Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.