Tuesday, June 2, 2015

A Dangerous Drug: Elixir Sulfanilamide


Once, a medicine with antifreeze in it was prescribed to children as a cure for sore throats. It ended up killing them. How did something like this ever manage to happen? Well, it all started with trying to make Sulfanilamide a liquid.

This incident was the Sulfanilamide disaster of 1937, which I recently learned about in my pharmacology class at the ROC taught by Dr. Sonia Houston Pichardo, PhD.

Sulfanilamides were the first powerful anti-bacteria drugs discovered in 1932 by Gerhard Domagk. They were used widely during World War II in powder and tablet form to prevent infection. In 1937 a drug manufacturer S. E. Massengill Co., decided sulfa drugs were so effective they should develop a liquid form to treat infection in children who couldn't easily swallow tablets.

The chemist in charge of the project, Harold C. Watkins soon found sulfanilamide dissolved in diethylene glycol, a clear odorless substance that tasted sweet. Perfect! Not. It ended up that diethylene glycol was a deadly poison used in antifreeze.



"Elixir Sulfanilamide" by Unknown

Back in 1937 there were no laws requiring that drugs be tested before being sold to the public so Elixir Sulfanilamide was put right on the market. In fact, at the time, there were no laws against selling lethal drugs at all. The FDA did exist, but it had little power and its Food and Drug Act of 1906 was not enforced. The new form of sulfanilmide was  prescribed to children without ever being tested.

Soon both kids and adults began do die as a result of taking Elixir Sulfanilamide and the American Medical Association suspected something fishy was going on and had this new drug form investigated. The symptoms of poisoning lasted about 7-21 days and resembled kidney failure. The drug meant to cure these kids of a sore throat ended up killing them in an excruciatingly painful way. The AMA found that diethylene glycol to be poisonous and ordered a swift recall of the drug. Still hundreds of people across the United States died, including Harold C. Watkins who committed suicide when he learned his drug was a killer

 The FDA and AMA recalled 234 gallons and 1 pint of the 240 gallons of Elixir Sulfanilamide distributed. Despite the horrible consequences of Elixir Sulfanilamide even getting on the market the only fine S. E. Massengill Co. was one for mis-branding, as the name "elixir" suggested alcohol was involved in the drug when it wasn't. If the drug had been called  Solution Sulfanilamide instead, the company would have received no fine at all.

The only good thing Elixir Sulfanilamide did was worry the government enough to make and enforce laws requiring drugs to be tested before they were put on the market. The Federal Food, Drug, and Cosmetics Act was put into practice in 1938.  Thank goodness! This law helped prevent anything like the Sulfanilamide disaster from ever happening on such a great scale again.




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