FDA acknowledges DES mistake
BOSTON Forty years after doctors at Massachusetts General Hospital first discovered a link between the drug Diethyl-stilbestrol (DES) and a rare form of cancer, the Food and Drug Administration (FDA) has sent a letter to Sens. John Kerry and Scott Brown acknowledging that the widespread prescription of DES was a tragedy with devastating health consequences.
The letter also outlines the FDA's new initiatives to prevent similar drug disasters in the future. This letter comes in response to a letter the senators sent to FDA Commissioner Margaret Ann Hamburg last October on behalf of constituents affected by DES.
"The FDA is the first line of defense for patients nationwide who need to know the medicines they use are safe, and it's important that today they've recognized the heartbreaking consequences that DES had for millions of people over the 30 years it was deemed safe," Kerry said.
"The FDA's acknowledgment of the devastating impact DES has had on patients across the country is long overdue, and I am pleased to hear of their admission," Brown said.
DES was a synthetic estrogen that was developed to supplement a woman's natural estrogen production. Originally prescribed by physicians in 1938 for women who experienced miscarriages or premature deliveries, DES was considered safe and effective for both mother and developing baby until the New England Journal of Medicine published a report in 1971 suggesting a link between DES use by pregnant women and a rare vaginal cancer in female offspring.
The FDA subsequently issued a drug bulletin to physicians advising them to discontinue prescribing DES in pregnant women.
According to the Centers for Disease Control, approximately 5 to 10 million people were exposed to DES between 1938 and 1971, including pregnant women and the children born from those pregnancies.