Sulfanilamide disaster

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Elixir sulfanilamide

The sulfanilamide disaster , also known as the Massengill disaster , occurred in the USA in 1937 when over 100 people, including many children, died after taking the "cold juice" Elixir sulfanilamide (active ingredient: the antibiotic sulfanilamide ) introduced in the same year . The easy-to-take, tasty dosage form was especially intended for children. The cause of the poisoning was the sweet, alcoholic compound diethylene glycol , which acted as a solvent in the antibiotic syrup, which was also flavored with a raspberry flavor.

In 1937, US legislation did not provide for adequate toxicity testing before a drug could be marketed. Doctor James Stevenson (died 1955) first noticed the link between child deaths from kidney failure and use of the drug and reported it to the American Medical Association , which immediately issued a warning. The further investigation took place at the competent authority, the US Food and Drug Administration (FDA). It was initially unclear whether the active ingredient sulfanilamide or auxiliary substances were responsible for the poisoning . It was not until the investigations of Frances Oldham Kelsey (who years later in her function as an employee of the FDA stubbornly and successfully opposed the approval application for a thalidomide- containing sleeping aid) uncovered the strong toxicity of diethylene glycol. The FDA employee Walter Campbell (1877-1963) urged the pharmaceutical company to recall the drug, of which a total of 23 liters had been sold in the United States by the time it was recalled. Although the manufacturer of the preparation, the small pharmaceutical company SE Massengill Co. in Tennessee, got away with what is now a small fine of $ 26,000, the sulfanilamide disaster - like the thalidomide scandal in Germany in 1961 and 1962 - turned into one Milestone in the history of consumer protection : In 1938, as a result of the tragic catastrophe, Congress passed the Federal Food, Drug, and Cosmetic Act .

Massengill's chief chemist, Harold Cole Watkins, initially defended himself against the allegations and took the drug himself in front of the press (without considering that children have different metabolic conditions). The affair hit him so badly that he committed suicide in 1939.

Individual evidence

  1. ↑ Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History ( Memento of May 12, 2009 in the Internet Archive ). Linda Bren, FDA Consumer Magazine, April / May 2001 issue.
  2. ↑ Derek Lowe, Das Chemiebuch, Librero 2017, p. 310.

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