FDA Approves New Oral Contraceptive Seasonale
The FDA on Friday approved Barr Laboratories' Seasonale, the first oral contraceptive created to reduce the number of menstrual cycles a woman has each year, the Washington Post reports. Seasonale is made with the same hormones and ingredients as conventional birth control pills but is packaged and prescribed differently. Patients take 84 active pills consecutively and then take seven placebo pills, compared with the usual regimen of 21 active pills with seven placebos. Such a regimen would limit menstrual periods to four per year, compared with 13 annually with current birth control pills (Stein, Washington Post, 9/6). In its approval, the FDA noted that about 7.7% of participants taking Seasonale in clinical trials withdrew from the studies because of "unacceptable" bleeding between periods, compared with 1.8% of women taking conventional oral contraceptives, the AP/Long Island Newsday reports. While Seasonale users had fewer menstrual periods, they were twice as likely to experience bleeding between periods than women taking conventional birth control pills, especially during the first few cycles of use, according to studies (Neergaard, AP/Long Island Newsday, 9/6). In addition, Seasonale, like conventional birth control pills, does not protect against sexually transmitted diseases and has an increased risk of cardiovascular complications for women who smoke (FDA release, 9/5).
The approval of Seasonale may indicate that menstrual suppression could "become more common," according to the AP/Newsday (AP/Long Island Newsday, 9/6). Many women already have been using conventional pills in a similar sequence to Seasonale to minimize the number of menstrual periods and period-related symptoms, such as cramps or bloating, the Post reports (Washington Post, 9/6). However, the Women's Health Network has said that proponents of Seasonale may imply that fewer menstrual periods are healthier, a message that they say is especially "unwise" for teenagers and young women, AP/Newsday reports (AP/Long Island Newsday, 9/6). The Society for Menstrual Cycle Research has issued a statement requesting further study of the safety of Seasonale, the Virginian-Pilot reports (Szabo, Virginian-Pilot, 9/6). Officials at Barr said that studies showed no difference in safety between the new pill regimen and traditional pill schedules, the New York Times reports (Grady, New York Times, 9/6). Dr. William Gibbons, chair of the Eastern Virginia Medical School department of obstetrics and gynecology, which partnered with Barr to research and patent Seasonale, said, "There isn't any definitive reason why women should have a period at all. ... There is the expectation that a lot of women will want this" (Virginian-Pilot, 9/6).
Barr spokesperson Carol Cox said that the company hopes to bring Seasonale to market by the end of next month. Sales of Seasonale may reach $16.2 million by the end of Barr's fiscal year in June 2004, according to Wachovia Securities research, Bloomberg/Philadelphia Inquirer reports. Barr CEO Bruce Downey said Barr -- which is currently the third-largest U.S. maker of oral contraceptives -- will "leapfrog" Johnson & Johnson and Watson Pharmaceuticals to become the largest U.S. manufacturer of oral contraceptives by the end of 2004, according to Bloomberg/Inquirer (Dodge, Bloomberg/Philadelphia Inquirer, 9/6). CBS' "Evening News" on Friday reported on Seasonale's approval. The segment includes comments from OB/GYN Dr. Shari Brasner and Seasonale clinical trial participants (Kaledin, "Evening News," CBS, 9/5). The full transcript of the segment is available online. The full segment is available online in RealPlayer. CNN's "American Morning" on Friday also reported on Seasonale. The segment includes comments from Dr. Susan Rako, author of "No More Periods!" and a Seasonale clinical trial participant (Gupta, "American Morning," CNN, 9/5). The full transcript of the segment is available online.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.