Elixirs of 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). 

Elixir of Sulfanilamide, containing a poisonous solvent, kiUs 107 people including children, drama-... 

The law of 1906 was only a beginning. It did not regulate the safety and effectiveness of drug formulations. This was no more evident than in the case of mass poisoning which resulted from the consumption of "elixir of sulfanilamide" produced by the S.E. Massengill Company of Bristol, Tennessee. Between September and October 1937 doctors had prescribed almost 12 gallons of a 10% solution of sulfanilamide in an ethylene glycol(antifreeze) solvent flavored with saccharin, caramel, amaranth, and raspberry extract. The company s chief chemist, Harold Watkins, was not aware of the toxicity of that concentration of the solvent. 

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