Approved April 1997
Pregnancy & Gynecology
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.
The Alesse drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.