Ask your doctor to change your oxycodone prescription to Rexista so we can learn for the first time about the effects on human beings of long-term twice-daily exposure to concentrated blue dye. If this were a true controlled study, you would have to sign a special ethics statement that you were aware that the concentrated blue dye could not possibly provide you with any benefit whatsoever.
Summary Food dyes, synthesized originally from coal tar and now petroleum, have long been controversial. Many dyes have been banned because of their adverse effects on laboratory animals. This report finds that many of the nine currently approved dyes raise health concerns.
Blue 1 was not found to be toxic in key rat and mouse studies, but an unpublished study suggested the possibility that Blue 1 caused kidney tumors in mice, and a preliminary in vitro study raised questions about possible effects on nerve cells. Blue 1 may not cause cancer, but confirmatory studies should be conducted. The dye can cause hypersensitivity reactions.
Blue 2 cannot be considered safe given the statistically significant incidence of tumors,particularly brain gliomas, in male rats. It should not be used in foods.
(Note: I'm not going to post the picture, but if you want to see what the blue skin looks like, there is a graphic photo of the blue infant on life support. You've been warned. This is Blue #1, almost certainly the blue dye that will be used in Rexista.)
The NEW ENGLAND JOURNAL of MEDICINE
Systemic Absorption of Food Dye in Patients with Sepsis N Engl J Med 2000; 343:1047-1048October 5, 2000DOI: 10.1056/NEJM200010053431416
Citing Articles (29)
To the Editor:
Critically ill patients who are receiving enteral feeding are susceptible to pulmonary aspiration of gastric contents. Measures to enhance the early detection of aspiration include the tinting of feedings with the food dye FD&C blue no. 1.1 During sepsis, gastrointestinal permeability increases because of enterocyte death and loss of barrier function at intercellular gaps. Thus, substances that are otherwise nonabsorbable may be absorbed during sepsis. We report two deaths associated with the systemic absorption of blue dye no. 1 from enteral feedings; in both cases, the absorption was heralded by the appearance of blue or green skin and serum.
A 54-year-old woman with chronic renal failure was hospitalized for congestive heart failure and confusion. Hemodialysis and nasogastric feeding were initiated. Later, staphylococcal pneumonia with sepsis was attributed to aspiration, prompting the addition of blue dye no. 1 to her enteral feedings. The patient was febrile but hemodynamically stable until two days later, when her skin and serum turned green. She died of refractory hypotension and acidosis that day.
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 (Figure 1FIGURE 1 Blue Discoloration of the Skin in a 12-Month-Old Boy Who Had Received Enteral Feedings Tinted with FD&C Blue Dye No. 1. ), serum, and urine became blue and hyperthermia developed (rectal temperature, 47°C). He died of refractory hypotension and acidosis that day.
Neither patient had bacteremia. Autopsies of both patients revealed green or blue discoloration of the skin and internal organs, without gastrointestinal perforation. Light-spectroscopic analysis of the child's serum and of the stock of blue dye no. 1 revealed identical, single absorption peaks at 629 nm (a peak that was absent in control serum), confirming the systemic absorption of dye. Although the blue tinting of feedings was visually titrated at our institutions, it is unlikely that oral-intake limits established by the Food and Drug Administration (FDA) for blue dye no. 1 (12 mg per kilogram of body weight per day)3 were exceeded. The adult patient had renal failure, which is notable given that this dye is cleared by the kidneys.
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. 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.
James P. Maloney, M.D. Medical College of Wisconsin, Milwaukee, WI 53226
Ann C. Halbower, M.D. Brian F. Fouty, M.D. Karen A. Fagan, M.D. Vivek Balasubramaniam, M.D. Adrian W. Pike, Ph.D. Paul V. Fennessey, Ph.D. University of Colorado, Denver, CO 80262
Marc Moss, M.D. Emory University, Atlanta, GA 30322
5 References
Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)
