The Elixir Tragedy

The Elixir Tragedy, 1937
A mass poisoning of 105 patients treated with an untested

medication spurred Congress to empower the US Food
and Drug Administration to monitor drug safety.
Jun 1, 2013
JEF AKST
LETHAL LIQUID: In 1937, the S.E.

Massengill Company of Bristol, Tennessee, began selling bottles of Elixir Sulfanilamide,
a liquid version of a popular antibiotic of the day. But more than 100 people died after
taking the drug, and investigators from the US Food and Drug Administration (FDA)
identified the drug’s solvent, diethylene glycol, as the killer.FDA HISTORY
OFFICE T
he US Food and Drug Administration’s role in the regulation of novel medicines
was born out of tragedy. Seventy-one adults and 34 children died in the fall of 1937 after taking
a drug called Elixir Sulfanilamide to treat a variety of ailments, from gonorrhea to sore throat. At
that time, the FDA, which had been launched in 1906 as the Bureau of Chemistry, served simply
to police claims made about food and drug ingredients. No formal government approval was
required to market new drugs.
“The initial 1906 legislation was relatively weak,” says Paul Wax, a medical toxicologist at the
University of Texas Southwestern Medical Center. “There had to be some truth to what [drug
companies] were selling . . . but in terms of safety, let alone efficacy, that wasn’t part of the
equation.”
That all changed in 1938, after the deaths linked to Elixir Sulfanilamide had become a national
scandal. Six years earlier, German pathologist and bacteriologist Gerhard Domagk discovered
that a chemical called prontosil protected against certain bacterial infections in mice. Further
research demonstrated that the compound’s active ingredient, sulfanilimide, could fight
streptococcal infections in humans, prompting several pharmaceutical companies—including
Merck, Squibb, and Eli Lilly—to begin making sulfanilamide drugs. These medicines were
mostly formulated as capsules and tablets, but the S.E. Massengill Company of Bristol,
Tennessee, decided that a liquid form of sulfanilamide could also be a big seller.
Massengill’s chief chemist concocted a solution of 10 percent sulfanilamide, 72 percent

diethylene glycol, and 16 percent water. The company’s internal control lab approved the
solution’s appearance, taste, and fragrance—it was flavored with raspberry extract, saccharin,
and caramel, among other ingredients—and by September 1937, Massengill had distributed 240
gallons of the liquid, called Elixir Sulfanilamide, across the country.
SAVING LIVES: Although the FDA didn’t regulate drug safety at the time, and therefore
had no authority to reprimand the company, the agency was able to track down and
seize bottles of Elixir Sulfanilamide on a technicality—“elixir” was a designation
reserved for drugs containing ethanol—an operation that saved as many as 4,000
lives.FDA HISTORY OFFICEBut commercial success soon soured, as the first deaths were
reported in October: six patients in Tulsa, Oklahoma, died of renal failure following treatment
with the drug. FDA Commissioner Walter Campbell immediately ordered the vast majority of
the agency’s 239 inspectors and chemists to investigate, and researchers quickly fingered the
medicine’s solvent, diethylene glycol, as the cause of the deaths. But under the regulations of the
time, Massengill hadn’t really done anything wrong: analyses of the concoction taken by the
Tulsa patients revealed the ingredients to be exactly what the company had said they were. (The
company had only broken the law by calling the medicine an “elixir,” a designation that was
reserved for drugs containing ethanol.)
The disaster provoked a public outcry that led to the passage of the 1938 Food, Drug, and
Cosmetics Act, which gave the FDA power to monitor the safety of new drugs. “Unfortunately,
it took a disaster like this to get the senators to vote and empower the FDA like it should have
been empowered to begin with,” says Wax, who has studied the Elixir Sulfanilamide tragedy
(Ann Intern Med, 122:456-61, 1995). It wasn’t until October 1962, however, that Congress
passed the Kefauver-Harris Drug Amendments, requiring companies to provide evidence of
efficacy, in addition to safety, for drug approval.
Keywords:
drug toxicity
FDA
food and drug administration
science history

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The Elixir Tragedy, 1937

A mass poisoning of 105 patients treated with an untested

LETHAL LIQUID: In 1937, the S.E.

Massengill’s chief chemist concocted a solution of 10 percent sulfanilamide, 72 percent

food and drug administration

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