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Thalidomide Tragedy And A Heroic FDA Hold
- The drug thalidomide was marketed as safe but caused thousands of fetal deaths and severe birth defects.
- Francis Oldham Kelsey at the FDA blocked its US approval and was later hailed as a hero.
Excluding Women Created Knowledge Gaps
- After thalidomide, the FDA broadly excluded women of childbearing potential from early trials to avoid fetal harms.
- That exclusion created a knowledge gap about drug effects in women for decades.
DES And Long-Delayed Harms To Offspring
- DES and thalidomide were prescribed to pregnant women and later shown to cause cancers and birth defects years later.
- These tragedies led the FDA in 1977 to recommend excluding most premenopausal women from early trials.