Yester
A bottle of Kevadon, the investigational US brand of thalidomide, from the FDA's historical collection.
1961Germany

Thalidomide Is Withdrawn After Birth Defects

A sedative sold as safe exposed gaps in how drugs were tested.

In 1957, the West German pharmaceutical manufacturer Chemie Grünenthal introduced thalidomide under the trade name Contergan. The firm's own researchers had synthesized and patented the compound in 1954. Advertised as a safe remedy for tension, anxiety, and sleeplessness, the drug was also aggressively promoted to pregnant women suffering from morning sickness. Crucially, the compound entered commercial distribution across forty-six countries without prior safety testing on pregnant women.

Within a few years of its launch, obstetricians and pediatricians began encountering an unprecedented surge in severe congenital disabilities. The substance acted as a potent teratogen during early embryonic growth, causing catastrophic interference if ingested between the twentieth and thirty-sixth day of gestation. It produced dysmelia, amelia, and phocomelia, an abnormality characterized by shortened or absent limbs, alongside malformations of the heart, eyes, ears, and internal organs. An estimated ten thousand to twenty thousand infants were affected worldwide, and infant mortality among the most severely affected may have reached forty percent.

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Sources

  1. Thalidomide-induced teratogenesis: History and mechanisms, by Neil Vargesson (Birth Defects Research, PMC)
  2. Vom Schlafmittel zum Krebsmedikament (Pharmazeutische Zeitung)
  3. Key dates in history of thalidomide (Associated Press, via The Washington Times)
  4. A Brief History of the Center for Drug Evaluation and Research (U.S. Food and Drug Administration)
  5. Frances Oldham Kelsey: Medical reviewer famous for averting a public health tragedy (U.S. Food and Drug Administration)
  6. Thalidomide: an unanticipated adverse effect (James Lind Library)
  7. William McBride, Who Warned About Thalidomide, Dies at 91 (New York Times, via WRAL)
  8. Thalidomide scandal

Image: The U.S. Food and Drug Administration