If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  FDA Clears Alesse, New Low-Dose Oral Contraceptive PHILADELPHIA, March 31, 1997 -- The world's most widely prescribed birth control pill combination, is now available in a lower dose. Today, the U.S. Food and Drug Administration (FDA) granted marketing approval for Alesse(TM) (100 mcg levonorgestrel/20 mcg ethinyl estradiol tablets), a new low-dose birth control pill. Alesse, indicated for the prevention of pregnancy, represents a new option for the many American women who choose the Pill as their form of contraception. New Alesse, developed by Wyeth-Ayerst Laboratories, 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. "This is an exciting time in the history of the Pill. The introduction of Alesse correlates with the trend toward lowering the dosage formulation of estrogen and progestin," said David Archer, M.D., Jones Institute for Reproductive Medicine, Eastern Virginia Medical School. "The clinical performance of Alesse indicates that the high level of safety and efficacy we expect in an oral contraceptive can be achieved with lower doses of these hormones." "The Pill is the most popular reversible contraceptive choice. Today, women are starting to take the Pill at a younger age and staying on it longer," continued Dr. Archer. "The introduction of Alesse represents a modern milestone in birth control pills," said Marc Deitch, M.D., Senior Vice President of Medical Affairs and Medical Director of Wyeth-Ayerst. "As the leader in hormone research and development for women, Wyeth-Ayerst strives to devise state-of-the-art oral contraceptive dosage combinations that provide today's women with effective contraception as well as the many noncontraceptive health benefits associated with the Pill." Alesse(TM), packaged in the Mini-Pack(TM), is available in 21- and 28-day regimens. The Mini-Pack(TM), 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 contraceptives, 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. Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with products in the areas of women's health care, cardiovascular and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines and generic pharmaceuticals. American Home Products is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It also is a leader in vaccines, biotechnology, agricultural products, animal health care and medical devices.
|
