Elixir sulfanilamide disaster of 1937. Presented by: Abhijit Pal Amit A tre Amrita P uranik Amrita K ulkarni Anjali I yer. Overview :. In 1937, at the dawn of the antimicrobial era, 105 people died after ingesting a sulfanilamide preparation known as Elixir Sulfanilamide .
Elixir sulfanilamide disaster of 1937
was passed by the U.S. Congress and signed
into law by President Franklin Delano
discovery that a chemical, prontosil, protected
against certain types of bacterial infections in mice .
About this time, the S.E. Massengill Company of Bristol, Tennessee, founded by Samuel E. Massengill (1871-1946), also began to produce sulfanilamide.
A solution of sulfanilamide had not been previously available because of the lack of an appropriate vehicle.
Harold Watkins, Massengill's chief chemist, was assigned the task of finding the right diluent.
After investigating several possible solvents, Watkins formulated a raspberry-tasting pink preparation.
The concoction was called Elixir Sulfanilamide despite the lack of ethanol.
Toxicity of the individual ingredients or the finished product was never tested.
By early September 1937, 240 gallons of Elixir Sulfanilamide had been manufactured by the Massengill Company.
One of the major points of delivery of the drug was Tulsa, Oklahoma.
On 2 October 1937, an editorial appeared in JAMA warning against an overzealous embrace of sulfanilamide.
Six patients from Tulsa had unexpectedly died from renal failure after ingesting Elixir Sulfanilamide.
The AMA then sent a telegraph to Dr. Massengill, requesting the composition of the elixir.
Massengill released this proprietary information but urged that it be kept strictly confidential.
Massengill Company sent out 1100 telegrams requesting the return of the elixir.
Researchers began to search for the etiologic agent.
Investigation focused primarily on the diluent —diethylene glycol.
of the FDA were limited.
The 1906 regulations were enforced by the Bureau of Chemistry in the Department of Agriculture.
In 1930, this unit became known as the FDA.
Under the 1906 law, in cases of suspected adulteration, drugs were tested for strength and purity.
The Elixir Sulfanilamide lacked
U.S. Congress passed resolutions
requesting a full investigation into the
One consequence of the regulations was the increasing practice of requiring prescriptions for the dispensing of certain drugs.
The 1951 Humphrey-Dunham Drug Prescription Act codified these trends.
Despite the vast improvements of the 1938 law, significant regulatory limitations remained.
1990, 40 children ranging in age from 6
months to 23 months died unexpectedly
from renal failure