Prescription Elixir Causes More than One Hundred Deaths Summary

  • Last updated on November 11, 2022

More than one hundred people, many of them children, died after taking a prescription drug known as elixir sulfanilamide, a new liquid form of the popular antibacterial drug sulfanilamide. Drug manufacturer S. E. Massengill sold the drug before performing pharmacological safety studies for toxicity. The scandal led to the passage of federal regulations aimed at curbing the unsafe manufacture and distribution of prescription and other drugs in the United States.

Summary of Event

In 1937, the Pharmaceuticals pharmaceutical company S. E. Massengill developed and sold a new product known as elixir sulfanilamide in response to demand for a liquid form of sulfanilamide, a popular antibacterial drug sold in tablet and powder form as a treatment for streptococcal infections. Sulfanilamide was part of a class of drugs known as sulfonamides (sulfa drugs), which were the forerunners of modern Antibiotics antibiotics. At the time, reformers were pushing for new legislation to replace the obsolete 1906 Food and Drug Act of 1906 Food and Drug Act, but that legislation was stalled in the U.S. Congress. Pharmaceutical companies faced little regulation in their attempts to develop new drugs, and they did not have to prove that their drugs were safe before putting them on the market. Massengill, Samuel Evans Watkins, Harold Cole Elixir sulfanilamide Sulfanilamide S. E. Massengill Company [kw]Prescription Elixir Causes More than One Hundred Deaths (Sept.-Oct., 1937) Massengill, Samuel Evans Watkins, Harold Cole Elixir sulfanilamide Sulfanilamide S. E. Massengill Company [g]United States;Sept.-Oct., 1937: Prescription Elixir Causes More than One Hundred Deaths[00640] [c]Corruption;Sept.-Oct., 1937: Prescription Elixir Causes More than One Hundred Deaths[00640] [c]Drugs;Sept.-Oct., 1937: Prescription Elixir Causes More than One Hundred Deaths[00640] [c]Ethics;Sept.-Oct., 1937: Prescription Elixir Causes More than One Hundred Deaths[00640] [c]Medicine and health care;Sept.-Oct., 1937: Prescription Elixir Causes More than One Hundred Deaths[00640] [c]Science and technology;Sept.-Oct., 1937: Prescription Elixir Causes More than One Hundred Deaths[00640] Kelsey, Frances Oldham Campbell, Walter

Massengill’s chief chemist, Harold Cole Watkins, developed elixir sulfanilamide when he discovered that sulfanilamide could be dissolved in diethylene glycol to create a liquid form of the drug. He then added raspberry flavoring and red coloring to improve the elixir’s taste, smell, and appearance. Watson had not read the current medical literature on Poisoning, diethylene glycol diethylene glycol and apparently did not know that the substance, commonly used as antifreeze, is a deadly poison that leads to kidney failure and a slow, painful death. No safety tests were required under existing drug laws, and Massengill did not conduct tests before shipping the elixir to fifteen U.S. states in September and October. The majority of the company’s shipments went to Oklahoma and Mississippi. None of the bottle labels identified diethylene glycol as an ingredient.

In early October, the American Medical Association American Medical Association began receiving reports from Tulsa, Oklahoma, doctors about patient deaths from kidney failure following ingestion of elixir sulfanilamide. An anonymous tip alerted the Food and Drug Administration, U.S.;and elixir scandal[elixir scandal] U.S. Food and Drug Administration (FDA) to the developing problem. The University of Chicago began a study of the elixir, and pharmacologist Frances Oldham Kelsey isolated diethylene glycol as the cause of the elixir’s toxicity.

The FDA soon sent inspectors to Massengill’s Bristol, Tennessee, headquarters and to its branch offices in other cities. Newspapers and radio announcements began to carry warnings against using the product. Massengill sent telegrams alerting salespeople, druggists and pharmacists, and doctors to return the product, but it did not warn that the elixir was toxic. The FDA insisted that the company send a second telegram stressing the deadly urgency of the situation.

The FDA then sought to track down and recall all shipments of the elixir, a difficult process for its field inspectors. State and local health officials aided in the search. The groups used shipping records and sales slips to track Massengill salespeople and the physicians and druggists to whom they had sold the product. They also sought to track down patients who had received prescriptions. Some druggists, however, had sold the elixir without a prescription, and some physicians lied to inspectors regarding patient deaths to avoid possible liability, which hindered the investigation. Most of the elixir, though, was recovered.

Scandal followed the deaths. Many of the victims were young children. The product’s liquid form and raspberry flavoring made it a popular choice among parents treating children with sore throats. Symptoms of diethylene glycol poisoning include severe abdominal cramps and pain, nausea and vomiting, headaches, blindness, convulsions, coma, and kidney failure. Relatives recounted that victims often thrashed in severe, unrelenting pain for several days (sometimes up to twelve days) before dying. There had been no known antidote or treatment. Anguished parents wrote letters to U.S. president Franklin D. Roosevelt, Franklin D. Roosevelt and First Lady Eleanor Roosevelt, Eleanor Roosevelt, describing their children’s horrible deaths. Prescribing doctors agonized over the deaths of their patients.

The FDA could take no action against Massengill for selling an untested drug because the company had violated no laws. Company director Samuel Evans Massengill also claimed that the company had violated no laws in developing and marketing elixir sulfanilamide and that it was not responsible for the resulting deaths. The only charge brought against the company was for misbranding: Products named an elixir had to contain alcohol, but elixir sulfanilamide had none. The company received the maximum fine allowed under the law: twenty-six thousand dollars. Without the charge of misbranding, the FDA would not have had the authority to track down and retrieve the distributed elixir. Massengill later fired Watkins, the chemist who had created the elixir. Watkins died after shooting himself while he was cleaning his own gun; many believe he committed suicide.

Impact

The widespread publicity and public outrage surrounding the elixir sulfanilamide scandal led to the passage of new, stricter standards for drug regulation in the United States. The public became much more cautious about the medicines it took and demanded that the federal government do more to protect consumers.

FDA commissioner Walter Campbell had been pressing for better federal regulation of drugs for years, and he used this scandal to highlight the importance of his cause. Shortly after the crisis, Congress enacted the Food, Drug, and Cosmetic Act of 1938 Food, Drug, and Cosmetic Act of 1938. The FDA received greater authority to regulate drugs manufactured and sold in the United States and required that drugs pass certain tests before they could be marketed. Laws against misbranding and false labeling also became much more stringent after the scandal. Drug labels had to include the common names of all active ingredients, and penalties were increased for violations of the new standards. The act not only protected the public but also spurred new medical research. Massengill, Samuel Evans Watkins, Harold Cole Elixir sulfanilamide Sulfanilamide S. E. Massengill Company

Further Reading
  • citation-type="booksimple"

    xlink:type="simple">Ballentine, Carol. “Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident.” FDA Consumer, June, 1981. Chronological recounting of the incident, the FDA’s role in tracing shipments of the elixir, and the agency’s role in pushing for new drug regulations.
  • citation-type="booksimple"

    xlink:type="simple">Hager, Thomas. The Demon Under the Microscope: From Battlefield Hospitals to Nazi Labs, One Doctor’s Heroic Search for the World’s First Miracle Drug. New York: Harmony Books, 2006. A history of the work of German bacteriologist Gerhard Domagk, whose studies led to the development of sulfa drugs. Includes a chapter on the 1937 elixir sulfanilamide scandal.
  • citation-type="booksimple"

    xlink:type="simple">Hilts, Philip J. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred A. Knopf, 2003. Discusses how tragedies and scandals such as the elixir sulfanilamide case helped in the development and betterment of FDA policy.
  • citation-type="booksimple"

    xlink:type="simple">Young, James Harvey. The Medical Messiahs: A Social History of Health Quackery in Twentieth-Century America. Princeton, N.J.: Princeton University Press, 1992. Young, a history professor and a member of the FDA’s National Advisory Food and Drug Council, offers an insider’s perspective on the elixir sulfanilamide case and its role in the passage of new FDA regulations.

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