Thursday, September 8, 1960: Thalidomide

The William S. Merrell Co. (Cincinnati, Ohio) submits a new drug application to the U.S. Food and Drug Administration for Kevadon, the brand name of a sedative -- thalidomide -- that had been marketed around the world since 1957. Citing safety concerns, the FDA refuses to approve the application and Kevadon would not be available for sale in the United States; however, thousands of patients in the U.S. still received Kevadon, as the company had sent samples to doctors for investigational use. The drug, which was also promoted as easing nausea during pregnancy, was later found to cause severe birth defects, affecting thousands of newborns worldwide (but far fewer in the United States). It would be pulled off the market in 1961 and 1962. (The ads shown here are for Distaval and Valgraine, which were among the brand names in England; click on image to see a larger version. More ads can be seen here.)

Note: Some resources put the application date as September 12; I used September 8, based on a statement given by Merrill's director of medical research to Congress in 1962.

* More about Francis Oldham Kelsey of the FDA, who refused to allow approval of the drug: @ and @ and @
* 2010 articles on Kelsey (New York Times, Washington Post): @ and @
* Thalidomide Victims Association of Canada: @

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