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| |  Low-Dose Birth Control Pill Provides Effective Treatment for Acne RARITAN, N.J., Jan. 2, 1997 -- For the first time, an oral contraceptive has been cleared for marketing by the U.S. Food and Drug Administration (FDA) as an effective treatment for acne in women seeking contraception. ORTHO TRI-CYCLEN(R) Tablets (norgestimate/ethinyl estradiol), manufactured by Ortho Pharmaceutical Corporation, is the first low-dose birth control pill cleared for marketing for a noncontraceptive indication since the Pill was introduced over 35 years ago. Acne is believed to be caused by a variety of factors, including hormones, stress and heredity. According to an American Academy of Dermatology (AAD) spokesperson, various estimates suggest that up to 40 to 50 percent of adult women suffer from some form of acne breakouts (i.e., pimples, whiteheads, blackheads). Although symptoms may begin in the teenage years, many women experience onset of symptoms in their 20s and 30s. Varying levels of severity of acne at different points of the menstrual cycle have been reported. Research has demonstrated that ORTHO TRI-CYCLEN decreases the level of hormones which contribute to the development of acne-producing agents, thus attacking the cause of the acne. In the clinical studies, ORTHO TRI-CYCLEN showed improvement of acne similar to that seen in studies looking at efficacy of benzoyl peroxide and topical or systemic antibiotics. ORTHO TRI-CYCLEN treats acne with a combination of ethinyl estradiol, a synthetic estrogen, and norgestimate, a progestin. Two randomized, double-blind, placebo-controlled studies demonstrated that improvement of acne was reported during use of ORTHO TRI-CYCLEN in more than 80 percent of the studies' participants treated with ORTHO TRI-CYCLEN. "This is great news for the millions of women with acne who take or want to take birth control pills," said Geoffrey Redmond, M.D., president of the Foundation for Developmental Endocrinology. "These studies suggest that ORTHO TRI-CYCLEN treats acne at its source by decreasing the level of hormones that contribute to the development of acne. ORTHO TRI-CYCLEN can give women a dual advantage -- pregnancy prevention and a proven treatment for acne." ORTHO TRI-CYCLEN, introduced in 1992, is the only oral contraceptive cleared in the U.S. for the treatment of moderate acne vulgaris in women 15 years of age or older, who have no known contraindication to oral contraceptive therapy, who desire contraception, who have begun menstruation and who are unresponsive to topical anti-acne medications. It is also indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. There are a variety of health benefits associated with the use of oral contraceptives like ORTHO TRI-CYCLEN, including reduced cramping, increased menstrual regularity and lighter menstrual flow. In addition, the Pill may decrease the incidence of acute pelvic inflammatory disease -- a condition which, left untreated, can cause infertility. Iron-deficiency anemia and ectopic pregnancies may also occur less frequently among Pill users. The Pill does not, however, protect users against sexually transmitted diseases, including HIV. Serious as well as minor side effects have been reported with the use of oral contraceptives. Physicians should remain alert to the earliest manifestations of any symptoms of serious disease and discontinue oral contraceptive therapy when appropriate. Ortho Pharmaceutical Corporation is a leader in women's health care. Since its founding in 1940, Ortho Pharmaceutical has played a pioneering role in contraception in the United States. Among its accomplishments are the introduction of the first low-dose oral contraceptive and the introduction of the first progestin-only oral contraceptive.
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