Warner Chilcott Begins Marketing First Chewable Oral Contraceptive

Warner Chilcott on Thursday announced that it has begun marketing Femcon Fe, the first and only FDA-approved chewable oral contraceptive, the AP/San Jose Mercury News reports (Johnson, AP/San Jose Mercury News, 12/10). FDA in November 2003 approved the chewable version of Northern Ireland-based Galen Holdings' oral contraceptive Ovcon 35. The chewable pills, which Bristol-Myers Squibb manufactures, contain progestin and estrogen -- the same hormones used in standard birth control pills. The pills will be available in a 28-day regimen with 21 white tablets containing norethindrone and ethinyl estradiol and seven green placebo pills that induce a menstrual period. Women will be able to chew the pills or swallow them whole; women who chew the pills must drink an eight-ounce glass of water afterward to ensure that the full dose reaches their stomachs. Femcon Fe has similar side effects to other birth control pills, such as an increased risk for blood clots, heart attack and stroke (Kaiser Daily Women's Health Policy Report, 11/17/03). One month's supply of the pill costs $44 wholesale. Warner Chilcott President Carl Reichel said the Femcon Fe package is a credit-card sized dispenser kept inside a velvet pouch that is slightly smaller than the "dial packs" in which birth control pills usually are packaged AP/San Jose Mercury News, 12/10). "Women who rely on the birth control pill tend to lead busy lives and have less time," Warner Chilcott CEO Roger Boissonneault said, adding, "We wanted to offer women a convenient, easy-to-use option for those 'on-the-go' with the same reliability as the traditional swallowed pill" (Warner Chilcott release, 12/8). According to several studies, one-third to nearly one-half of women taking oral contraceptives fail to take one or two pills per month, increasing their chances of pregnancy. Lee Shulman, chair of the Association of Reproductive Health Professionals, said, "This isn't a great leap forward, but I think this is a helpful step," adding, "I think this is a better approach in the group of women who have a very high rate of unintended pregnancy, which is younger women" AP/San Jose Mercury News, 12/10).

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