Possible increased risk of ovarian cancer with fertility drugs

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At FDA's request, drug firms are revising fertility drug labels to include ovarian cancer as a potential adverse drug reaction.

FDA acted last January in response to recent data indicating that use of these drugs may have a stronger association with the disease in women who have never been pregnant than previously believed.

Since fertility drugs were first marketed, at least 12.5 million courses of the drugs have been prescribed in the United States to women unable to conceive. (FDA approved Clomid [clomiphene citrate] in 1967 and Perganol [menotropins] in 1974.) In that time, FDA has received reports of six cases of ovarian cancer associated with their use.

An article in the November 1992 issue of the American Journal of Epidemiology reported an analysis of data from 12 studies comparing women with ovarian cancer to those without the disease. Only three of the studies, however, contained data on the use of fertility drugs and risk of ovarian cancer. The analysis found a risk of ovarian cancer among women who had never been pregnant, had been diagnosed as infertile, and had been treated with fertility drugs. It did not find a relationship between the disease and use of the drug in women who had been pregnant at least once.

The report looked at 34 women with ovarian cancer and 23 women without the disease. Twelve of the 34 with the disease had used fertility drugs, while only one of the 23 healthy women had used them.

FDA urges caution in interpreting the findings because the analysis only includes small numbers of women and because the article gives no information about the fertility drugs prescribed, reasons for the infertility, or tumor size or stage of disease at diagnosis. (A 1987 article in the same journal reported no association between the drugs and ovarian cancer.)

Analyzing other factors, the authors concluded that pregnancy, use of contraceptives, and breast-feeding all had a protective effect against development of ovarian cancer.

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