Nafarelin for endometriosis
Article Abstract:
The Food and Drug Administration has recently approved nafarelin acetate, a nasal spray, to be used as a treatment for endometriosis. Endometriosis is a condition in which there is growth of endometrium (uterine tissue) in various pelvic or abdominal sites, which responds to monthly variations in female hormones. This can result in pain and infertility. Nafarelin acetate is a synthetic drug that mimics gonadotropin-releasing hormone (GnRH), which stimulates the pituitary gland to release follicle-stimulating hormone (FSH) and luteinizing hormone (LH). The drug acts in a nonpulsatile fashion, causing an initial rise and then suppression of these hormones. The labeling indicates that 30 to 60 percent of patients in controlled studies remained symptom-free for one year with nafarelin treatment. Adverse effects are chiefly associated with estrogen deficiency, such as hot flashes, decreased sex drive, vaginal dryness, mood changes, headaches, and acne. Bone mass reduction and mineral content loss is another adverse consequence of low estrogen that is associated with nafarelin treatment. This drug is also capable of causing birth defects and should not be used without a barrier contraceptive if a woman is sexually active. The long-term use of other GnRH agonists have been shown to cause abnormal tumors and growths in the endocrine organs of laboratory rodents. This drug is not recommended for women under 18-years of age, and should not be used for more than six months because of possible bone loss. Re-treatment is not recommended, and the symptoms are apt to recur after the drug is stopped. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Medical Letter on Drugs and Therapeutics
Subject: Health
ISSN: 0025-732X
Year: 1990
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Assessment of safety
Article Abstract:
Depot leuprolide acetate and danazol seem to have similar side effects and similar effectiveness in the treatment of symptomatic endometriosis. The endometrium is the tissue that lines the uterus. Growth of this tissue outside the uterus is known as endometriosis. Women were randomly assigned to be treated for 24 weeks with either danazol or leuprolide acetate. One hundred thirty-four women received monthly injections of leuprolide and 136 took daily doses of danazol orally. The most significant side effect of leuprolide acetate was a loss of bone mineral density. Early evidence suggests that this decrease can be reversed after discontinuation of treatment, but further research is needed. The most significant side effect associated with danazol was that levels of high-density lipoproteins were lowered, sometimes below the normal range. These effects may also be reversible, but again, further study is needed. Other side effects, such as hot flushes and acne, were reported by 94% of the leuprolide patients and 90% of the danazol group. Few women withdrew from the study or complained of severe side effects.
Publication Name: American Journal of Obstetrics and Gynecology
Subject: Health
ISSN: 0002-9378
Year: 1993
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Amniotic fluid insulin testing in gestational diabetes: safety and acceptance of amniocentesis
Article Abstract:
Women who develop diabetes during pregnancy may feel comfortable with having amniocentesis for insulin testing in the third trimester. Researchers compared the effects of amniocentesis and its acceptance by 194 pregnant women with gestational diabetes and 268 controls. Patient acceptance was generally high and side effects were rare. Nine women prematurely ruptured their membranes after amniocentesis.
Publication Name: American Journal of Obstetrics and Gynecology
Subject: Health
ISSN: 0002-9378
Year: 1998
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