FDA Alert
Here's an interesting piece of news from PDR.net regarding food dye:
FDA Alert Issued for FD&C Blue No. 1
The FDA has issued an alert for healthcare professionals regarding reports of toxicity, including death, associated with the use of FD&C Blue No. 1 (Blue 1) in enteral feeding solutions. In these reports, Blue 1 was intended to help in the detection and/or monitoring of pulmonary aspiration in patients being fed by an enteral feeding tube. Episodes of blue discoloration of the skin, urine, feces, or serum were reported, as well as serious complications such as refractory hypotension, metabolic acidosis and death. Seriously ill patients, particularly those with a likely increase in gut permeability (eg, patients with sepsis), were reported to be at greater risk for these complications. A causal relationship between systemic absorption of Blue 1 and the reported serious and life-threatening patient outcomes (including death) has not been definitively established.
Now, for those of you who don't know, use of the blue food coloring in enteral feeding (tube feeding solution) is absolutely routine. As the excerpt states, it's used to identify the feeding solution in case the patient chokes or you have reason to think they are aspirating chronically. My question is, with use of this stuff so ubiquitous (at least in California) wouldn't this have been picked up sooner if it were truly a problem? And the article itself states that no definite association has yet been established.
In addition, this population is extremely ill and at higher than average risk for having complications to start with. The tube itself has the potential to cause problems (insertion site infections and so forth). I'd really have liked to be able to see the data on this. That said, even a low risk should be avoided if there is an alternative. (Green, anyone?)
If anyone has more info on this, I'd be very interested to hear it.
posted by Dr. Alice at #
