Elixir sulfanilamide tragedy

As increasing numbers of people experience the ill effects of medication use and realize that this is not an inevitable consequence of our health care system, the public outcry for answers will intensify. Medication safety has been the driving force for many health care advances, such as the 1937 Elixir Sulfanilamide scandal (FD C Act), the European thalidomide tragedy (1962 Kefauver Drug Amendments), and the incidence of adverse drug events in nursing homes (1974 Consultant Pharmacists Law). ... 

In practice, it is impossible to obtain medication of 100 % purity, which makes it necessary to check the impurity profile of the dmg. Investigations involve the isolation, identification, and quantification of the impurities, and in many cases define their biological activity and toxicity. Performing such studies is an important part of the development of a dmg and is a part of safe pharmacotherapy. The goal is to prevent tragedies, such as one in 1938 when 105 people died after administration of Elixir Sulfanilamide that was contaminated with diethyl glycol [6]. 

Federal Food, Drug, and Cosmetic (FD C) Act. Tragedy Sulfanilamide elixir made with poisonous solvent causes 107 deaths. Result Requires manufacturers to prove the safety of products before marketing. 

Although the special nature of children in clinical trials is dealt with elsewhere in this book, it should not be forgotten that the FDA has been influenced to make regulatory changes specific to this age group as well. The victims of the sulfanilamide elixir tragedy that drove the 1938 Food, Drug and Cosmetic Act were mostly children. 

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