Elixir sulfanilamide: Difference between revisions

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'''Elixir Sulfanilamide''' is a medication that was introduced in the 1930s. It was a solution of [[sulfanilamide]], an early [[antibiotic]], in [[diethylene glycol]]. Unfortunately, the use of diethylene glycol as a solvent resulted in the deaths of more than 100 people, leading to significant changes in [[drug regulation]] in the United States.
{{short description|A historical pharmaceutical disaster}}


== History ==
[[File:Elixir_Sulfanilamide.jpg|thumb|right|Elixir Sulfanilamide, a toxic preparation that led to a public health disaster.]]


Elixir Sulfanilamide was introduced by the [[S.E. Massengill Company]] in 1937. The company used diethylene glycol as a solvent without realizing that it was toxic. The resulting product was a sweet-tasting, raspberry-flavored liquid that was marketed as a treatment for various infections.
'''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.


The product was distributed widely and quickly led to a public health crisis. More than 100 people, many of them children, died after taking the medication. The incident led to widespread public outrage and significant changes in drug regulation in the United States.
==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.


== Impact on Drug Regulation ==
==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."


The Elixir Sulfanilamide incident was a major factor in the passage of the 1938 [[Food, Drug, and Cosmetic Act]], which significantly expanded the powers of the [[Food and Drug Administration]] (FDA). The new law required companies to perform safety testing on their products before they could be marketed. It also required that drugs be labeled with accurate information about their contents and dosage instructions.
==Toxicity and Public Health Impact==
[[File:Elixir_Sulfanilamide.jpg|thumb|left|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.


== See Also ==
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.


* [[Sulfanilamide]]
==Regulatory Response==
* [[Food, Drug, and Cosmetic Act]]
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.
* [[Food and Drug Administration]]


== References ==
==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.


<references />
==Related pages==
* [[Federal Food, Drug, and Cosmetic Act]]
* [[Sulfanilamide]]
* [[Diethylene glycol poisoning]]
* [[History of drug regulation in the United States]]


[[Category:Medicine]]
[[Category:Pharmaceutical disasters]]
[[Category:Pharmacy]]
[[Category:1937 in the United States]]
[[Category:History of Medicine]]
[[Category:History of medicine]]
[[Category:Drug Regulation]]
{{stub}}

Latest revision as of 05:36, 16 February 2025

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[edit]

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[edit]

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[edit]

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[edit]

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[edit]

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[edit]