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 .
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 .
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.
The concoction was called Elixir Sulfanilamide despite the lack of ethanol.
Toxicity of the individual ingredients or the finished product was never tested.
One of the major points of delivery of the drug was Tulsa, Oklahoma.
Six patients from Tulsa had unexpectedly died from renal failure after ingesting Elixir Sulfanilamide.
Massengill released this proprietary information but urged that it be kept strictly confidential.
Researchers began to search for the etiologic agent.
Investigation focused primarily on the diluent —diethylene glycol.
of the FDA were limited.
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