Sulfanilamide Disaster

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Unfortunate events have catalysed the development of medicines regulation more than the evolution of a knowledge base. In 1937 the death of over 100 people in the United States by using a Sulfanilamide elixir is one such event.
In the 1930s, Sulfanilamide, a drug used to treat streptococcal infections, had been shown to have dramatic curative effects used as a tablet and powder form. As a result there was a demand for the drug in a liquid form.

In 1937, S.E. Massengil Company created a liquid preparation after experiments showed that sulfanilamide would dissolve in diethylene glycol. The company control lab tested the mixture for flavour, appearance, and fragrance and found it satisfactory, and the product was marketed as “Elixir of Sulfanilamide”. Therefore, the elixir was manufactured in large quantity and distributed across the country.
Within one month, a number of deaths related to the sulphanilamide elixir were reported to the American Medical Association (AMA). The AMA tested the compound and found the excipient, diethylene glycol, as the toxic ingredient.
FDA was notified and they then set out to retrieve the entire drug from across the country. However, by that time 353 patients had received the “Elixir” during a 4-week period resulting in more than 100 deaths (including children), about a 30% fatality rate.
It was found that Diethylene Glycol, a chemical used as antifreeze, is a deadly poison.

GCP Principles violated:
Although there were no GCP guidelines or federal regulations demanding safety testing for drugs in 1937, the sulfanilamide elixir case violated a number of GCP principles.
• The first GCP principle requires ethical conduct of a clinical trial, which have their origin in the Declaration of ...

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...ce (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forti- eth report. Geneva: WHO; 2006 [cited 2008 Jan 19]. p. 347-390. (WHO Technical report series; no 937, annex 7). Available from: URL: medicines/publications/pharmprep/en/index.html
WHO. International nonproprietary names (INN) for pharmaceutical substances [CD-ROM]. Geneva: World Health Organization; 2007. Available from: URL: qsearch1.jsp?sesslan=1
WHO. Quality assurance of pharmaceuticals. A com- pendium of guidelines and related materials, vol 2, 2nd update ed. Good manufacturing practices and inspec- tion. Geneva: World Health Organization; 2007.
Drug Regulation: History, Present and Future 77

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