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Danazol

Danazol is a derivative of the synthetic steroid ethisterone, a modified testosterone. It was approved by the FDA as the first drug to treat specifically endometriosis, but its role as a treatment for endometriosis has been largely replaced by the GnRH agonists. more...

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The agent is fat-soluble, has a molecular weight of 337.5. Its CAS registry number is 17230-88-5.

Danazol decreases the pituitary hormones FSH and LH and exerts an antiproliferative effect upon the endometrium, leading to amenorrhea. This effect is useful for patients with endometriosis. Commonly, pelvic pain associated with endometriosis is improved as well.

Androgenic side effects are of concern as in sensitive female individuals, Danazol can enhance unwanted heir growth leading to hirsutism. On rare occasion, it may deepen the voice. Other side effects could be acne and oily skin. As Danazol is metabolized by the liver, it cannot be used by patients with liver disease, and long-term use needs to monitor liver function on a periodic basis. Some patients who use Danazol may experience weight gain and fluid retention.

Contrary to GNRH agonists Danazol does not induce osteoporosis. Also, symptoms of hot flashes tend to be less common or severe.

Danazol is contraindicated in pregnancy as it could masculinize a female fetus.

Danazol has been used for other indications, namely in the management of menorrhagia, of fibrocystic breast disease, and of hereditary angioedema.

In the USA, Danazol was initially marketed as Danocrine, before it became available as a generic drug.

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Danazol may be linked to rise in ovarian cancer, small study finds - Risk raised two-to threefold
From OB/GYN News, 9/1/02 by Sharon Worcester

MIAMI BEACH--Danazol use may be associated with increased risk for ovarian cancer, the results of a small study suggest.

In the study, which included pooled data from two case-control studies, women who used danazol were nearly three times more likely to develop ovarian cancer than were those using leuprolide, Dr. Roberta B. Ness reported at the annual meeting of the Society of Gynecologic Oncologists.

Of 1,373 women with ovarian cancer, 195 also had endometriosis; of 1,980 control patients without ovarian cancer, 195 had endometriosis. Of the 195 ovarian cancer/endometriosis patients, 12 had used the synthetic androgen danazol to treat their endometriosis, and 8 had used the antiandrogenic gonadotropin-releasing hormone agonist Lupron; of the 195 controls, 5 had used danazol, and 7 had used leuprolide, said Dr. Ness of the University of Pittsburgh.

Previous studies have shown that women with endometriosis have up to a 50% greater risk of developing ovarian cancer than other women. In this study, women with endometriosis were 1.5-fold more likely to develop ovarian cancer. The use of danazol seems to further increase the risk of ovarian cancer in women with endometriosis, said Dr. Ness, who is also director of the Epidemiology of Women's Health Program at the university.

Among all of the patients, leuprolide use was found to be associated with a slightly increased risk of ovarian cancer (odds ratio 1.4), but Dr. Ness attributed that finding to the fact that most of the women using leuprolide had endometriosis. In an analysis of only the women with endometriosis, the association diminished (odds ratio 1.2), she noted at the meeting, also sponsored by the American College of Surgeons.

Danazol use, however, increased the risk of ovarian cancer substantially, both in the entire study population (odds ratio 3.6) and in those with endometriosis (odds ratio 2.3).

Repeated telephone calls seeking comment on the study were not returned by New York-based Sanofi-Synthelabo Inc., which manufacturers a widely used brand name formulation of danazol called Danocrine.

The findings support the hypothesis that androgens play a role in ovarian cancer, and while the number of women treated with danazol and leuprolide in this study was small, the findings raise concerns that warrant further study of potential risks tied to danazol.

COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2002 Gale Group

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