FDA’s November 1971 Alert About DES

7 May

In the late 1960s, there was an unprecedented appearance of rare cancer in young women. Clear cell cancer (CCA) – a rare cancer of the vagina – was diagnosed in an age group never before found to develop it. (Normally elderly women developed CCA.) There were eight such cases at Massachusetts General Hospital in Boston alone. One of the mothers raised the question of whether her daughter’s cancer might be connected to DES exposure in utero. Doctors discovered the DES cancer link in 1971 and published their findings in the April 1971 issue of New England Journal of Medicine. News of the cancer cases made national headlines. However, the FDA did not act on this information until public pressure, including Congressional Hearings, forced the FDA to issue a warning about DES in November 1971. The drug was not banned for human use. DES was contraindicated for pregnancy by the FDA in 1972. It wasn’t until September 2000 that the FDA finally withdrew its approval of DES for humans.

View the FDA’s November 1971 alert about DES HERE.

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