Diethylene glycol Sulfanilamide

Geihng E, Cannon P. Pathogenic effects of elixir of sulfanilamide (diethylene glycol) poisoning. A clinical and experimental correlation. Final report. Journal of the American Medical Association, 1938,111 919-926. 

It should never be lost sight of that one of the major reasons for the 1938 FD C Act was a public health disaster caused by a drug formulation mistake. In the 1930s, the Massengill Company s use of diethylene glycol in elixir of sulfanilamide led to 105 deaths. This same disaster was, by the way, repeated in Haiti in 1995 and 1996 (O Brien et al., 1998). Such considerations are also overlooked in clinical safety evaluations, though the history of their directly and indirectly causing problems, even to the current day, is extensive (Winek, 2000). 

Campbell and his staff anticipated that the battle in court would be hard fought. They knew that company agents had been active gathering affidavits from patients who had used Elixir Sulfanilamide and who would testify that they had not been harmed ( 55). Some would say that the medicine had helped them. Perhaps as many as 680 such documents, the FDA believed, had been collected (60). It was also anticipated that the company intended to assert that sulfanilamide afflicted the same proportion of patients who took it alone as had been afflicted while taking it mixed with diethylene glycol, about fifteen percent in both circumstances. 

A Division of Pharmacology had been formally set up in the Food and Drug Administration in 1935, composed mostly—as one of its members, Edwin P. Laug, remembered—of "biochemists who then changed sails and became pharmacologists" (7] ). To study the toxicity of lead and arsenic pesticide residues formed the division s initial purpose, but the Elixir Sulfanilamide crisis brought an almost total shift of effort to diethylene glycol. 

But, oblivious to all of this, Massengill manufactured and distributed 240 gallons of Elixir Sulfanilamide in September of 1937. By October reports of deaths had come in, but the company refused to shoulder any of the blame. Massengill spokesmen maintained that they had broken no laws. Furthermore, they refused to divulge the contents of the formula because it was a trade secret. Finally, under pressure from the American Medical Association, the company revealed that the eUxir contained diethylene glycol. The nature and scope of the problem was now clear, and the American Medical Association, the fda, and the media joined forces in a massive effort to track down as much of the elixir as possible. They were astonishingly successful 234 of the 240 gallons were recovered. 

This substance is a liquid used in antifreeze, paints, polishes, and cosmetics. As it has a sweet taste and is readily available it has been used as a poor man s alcohol, but it may also be ingested accidentally and for suicidal purposes. Diethylene glycol was once used as a vehicle for the drug sulfanilamide, and when used for this, it caused some 76 deaths. 

Elixir sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107,... 

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