Elixir sulfanilamide

A historical pharmaceutical disaster

Elixir Sulfanilamide, a toxic preparation that led to a public health disaster.

Elixir Sulfanilamide was a pharmaceutical preparation that caused a significant public health disaster in the United States in 1937. The incident led to the deaths of over 100 people and prompted the passage of the 1938 Federal Food, Drug, and Cosmetic Act.

Background

Sulfanilamide was one of the first antibiotics used to treat bacterial infections. It was effective against a wide range of infections and was widely used in the 1930s. However, the compound was not very soluble in water, which made it difficult to formulate as a liquid medication.

Development of Elixir Sulfanilamide

In 1937, the S.E. Massengill Company, a pharmaceutical manufacturer, developed a liquid form of sulfanilamide by dissolving it in diethylene glycol, a chemical commonly used as an industrial solvent and antifreeze. The resulting product was marketed as "Elixir Sulfanilamide."

Toxicity and Public Health Impact

The toxic effects of Elixir Sulfanilamide were due to the presence of diethylene glycol.

Diethylene glycol is highly toxic to humans, and its ingestion can lead to renal failure, neurological damage, and death. The use of diethylene glycol in Elixir Sulfanilamide was not tested for safety, and the product was released to the market without adequate safety evaluations.

The consumption of Elixir Sulfanilamide led to mass poisoning, with over 100 reported deaths, including many children. The symptoms of poisoning included severe abdominal pain, vomiting, convulsions, and kidney failure.

Regulatory Response

The Elixir Sulfanilamide disaster highlighted the need for stricter regulations on drug safety. In response to the tragedy, the United States Congress passed the Federal Food, Drug, and Cosmetic Act of 1938. This legislation required that drugs be tested for safety before being marketed and gave the Food and Drug Administration (FDA) the authority to oversee drug safety.

Legacy

The Elixir Sulfanilamide incident is often cited as a pivotal moment in the history of drug regulation. It underscored the importance of rigorous safety testing and the need for regulatory oversight to protect public health. The tragedy also raised public awareness about the potential dangers of untested pharmaceuticals.

Related pages

• Federal Food, Drug, and Cosmetic Act
• Sulfanilamide
• Diethylene glycol poisoning
• History of drug regulation in the United States