The "Safe and Effective" History of Thalidomide and the Thalidomide Babies
Thalidomide is a medication that was originally developed in the late 1950s by the German pharmaceutical company Chemie Grünenthal GmbH. It was marketed as a sedative and hypnotic drug and was prescribed to treat insomnia, anxiety, and morning sickness in pregnant women.
Initially, thalidomide was seen as a miracle drug, as it was effective in treating a range of conditions and had few side effects. However, in the early 1960s, reports began to emerge of babies being born with severe birth defects, such as limb abnormalities, deafness, blindness, and heart defects. It was soon discovered that these birth defects were directly linked to the use of thalidomide during pregnancy.
The exact mechanism by which thalidomide causes birth defects are not completely understood, but it is believed to be related to its ability to interfere with the development of blood vessels and other structures in the developing embryo.
The discovery of the link between thalidomide and birth defects led to a worldwide scandal, and the drug was pulled from the market in many countries. In the United States, the FDA never approved thalidomide for sale, in large part because of the efforts of Frances Oldham Kelsey, an FDA reviewer who refused to approve the drug due to insufficient evidence of its safety.
In the years since the thalidomide scandal, efforts have been made to provide compensation and support to the thousands of people who were affected by the drug. Thalidomide has also been rediscovered as a treatment for certain types of cancer and inflammatory diseases, but its use is heavily regulated to prevent a recurrence of the birth defects that were seen in the 1960s.
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References
Frances Kelsey and the FDA: https://www.fda.gov/about-fda/frances-kelsey-and-fda
Thalidomide and limb abnormalities: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3047692/
Thalidomide and birth defects: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3945272/
Thalidomide and cancer: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2877885/
Thalidomide and inflammatory diseases: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3799623/
Image: The First Appearance of Thalidomide
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