Elixir sulfanilamide disaster

Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937. It caused the deaths of more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act.

Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control in the United States of America ensuring the safety of new drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisoning crisis.

In 1937, S. E. Massengill Company, a pharmaceutical manufacturer, created a preparation of sulfanilamide using diethylene glycol (DEG) as a solvent, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans and other mammals, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this. (Though the first case of a fatality from ethylene glycol occurred in 1930 and studies had been published in medical journals stating DEG could cause kidney damage or failure, its toxicity was not widely known prior to the incident.) Watkins simply added raspberry flavoring to the sulfa drug which he had dissolved in DEG and the company then marketed the product. Animal testing was not required by law, and Massengill performed none; there were no regulations requiring premarket safety testing of new drugs.

The company started selling and distributing the medication in September 1937. By October 11, the American Medical Association received a report of several deaths caused by the medication. The Food and Drug Administration was notified, and an extensive search was conducted to recover the distributed medicine.Frances Oldham Kelsey assisted on a research project that verified that the excipient DEG was responsible for the fatal adverse effects. At least 100 deaths were blamed on the medication.

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