Food dye implicated in U.S. patient deaths

BOSTON, Massachusetts (Reuters) - A widely-used blue food dye may have contributed to the deaths of three critically ill patients after it was used to color the liquid food pumped into their stomachs, according to a report in Thursday's New England Journal of Medicine.

The three had eaten food with FD&C blue dye No. 1 and their skin and blood turned a bluish-green hours before they died, Dr. James Maloney of the Medical College of Wisconsin told Reuters.

A report on two of three cases originated in Denver, Colorado, and they are reported in the Journal. The third case will be presented at a conference in January.

The dye, made from coal tar, is routinely added to the liquid to help doctors see if any of the food is escaping from the stomach and being inhaled. In healthy people, the dye never leaves the digestive tract.

But these cases involved patients who had digestive tract tissues being destroyed by sepsis, an infectious condition.

Maloney and his colleagues said the damage apparently allowed the dye to get into the bloodstream, causing a deadly drop in blood pressure and an increase in acid levels in the body.

One patient was a 54-year-old woman with heart failure. In 1995, two days after her food was colored with the dye, her skin and blood turned green and she died.

The other victim described in the Journal was a one-year-old boy with sepsis who died in 1998 of the same cause on the day his skin, blood and urine turned blue.

"Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color," the researchers said.

The third case involved an elderly woman from Wisconsin.

Maloney said there have been other instances, none of them fatal, where seriously ill recipients of the dye have turned color, but the incidents have been sporadic.

The researcher said the dye is not dangerous to the vast majority of people. Because it is only in seriously ill patients that it might be a remote threat, as a precaution, Maloney said "we're trying to convince people not to use it in any hospitalized patients."

The dye, manufactured by a variety of companies, was approved in the 1960s by the U.S. Food and Drug Administration, which performed other safety tests early in the 1980s. Those experiments showed that the dye was safe and the body didn't absorb it. But those tests were performed on healthy animals, the Maloney team noted.

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