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Female Doctor Prevented Sale of Thalidomide in U.S.

July 15, 1962 - A woman doctor was reported today to have prevented the birth of perhaps thousands of deformed babies in this country. She is Dr. Frances Oldham Kelsey (pictured), a 47-year-old specialist and reviewer with the Food and Drug Administration. The case involves a drug called thalidomide and a rare birth defect known as phocomelia, in which limbs are missing. Thalidomide was developed in West Germany in the 1950s and found to be an effective sleep-inducer. In 1960, the William S. Merrill Company of Cincinnati requested FDA clearance to market it in this country. Dr. Kelsey was not convinced that the drug was safe and repeatedly refused to approve it. Then in 1961, a number of cases of phocomelia broke out in Europe. A Hamburg pediatrician found that 50% of the mothers of deformed infants who came to his clinic had taken thalidomide. The drug was taken off the market in Germany and elsewhere.

#FDA #drugs #thalidomide