Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Obstetrics/Gynecology (Women’s Health)
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Alesse (100 mcg levonorgestrel/20 mcg ethinyl estradiol tablets)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved April 1997
Treatment Area: birth control
Alesse (100 mcg levonorgestrel/20 mcg ethinyl estradiol
tablets), a new low-dose birth control pill, has been approved for
marketing. New Alesse represents the lowest dose combination of
levonorgestrel and ethinyl estradiol marketed in the United States.
Alesse contains 100 mcg of the progestin levonorgestrel, the most
widely prescribed contraceptive progestin, and 20 mcg of ethinyl
estradiol, the estrogen most frequently used in oral
contraceptives. More than 40 percent of oral contraceptive
prescriptions worldwide contain levonorgestrel and ethinyl
estradiol. Alesse, packaged in the Mini-Pack, is available in 21-
and 28-day regimens. The Mini-Pack, developed by Wyeth-Ayerst,
represents the smallest oral contraceptive packaging available. It
has several convenient features to help women remember to take
their birth control pill daily and in the prescribed sequence.
Alesse, like other oral contraceptive, has proven to be more
than 99 percent effective when taken as directed. In addition,
birth control pills may provide protection from ovarian and
endometrial cancer and pelvic inflammatory disease. They also may
make a woman’s period less painful by reducing cramps and increase
menstrual cycle regularity. Women who use Alesse or other oral
contraceptives may experience iron-deficiency anemia and ectopic
pregnancy less frequently.
Common side effects associated with oral contraceptives include
nausea, headache and breast tenderness. Serious side effects occur
infrequently, especially if a woman is in good health and does not
smoke. These may include blood clots, heart disease, stroke, liver
tumors and gallbladder disease. Several studies have found no
overall increase in the risk of developing breast cancer in women
taking oral contraceptives. Some women should not use oral
contraceptives, including those who have had blood clots, certain
cancers, or a history of heart attack or stroke, as well as those
who are or may be pregnant.
Cigarette smoking increases the risk of serious cardiovascular
side effects. This risk increases with age and is most pronounced
in women older than age 35. Women on oral contraceptives should not
smoke. In addition, oral contraceptives do not protect a woman
against HIV infection or other sexually transmitted diseases.