FDA Asks Wyeth To Submit More Data On Oral Contraceptive That Stops Menstrual Bleeding, Company Says

Wyeth on Wednesday said it has received an "approvable" letter from FDA for its oral contraceptive pill Lybrel, which can eliminate women's monthly periods if taken consistently throughout the year, the Wall Street Journal reports. The letter indicates that the agency might approve the product but only after receiving more data on it, according to the Journal (Wall Street Journal, 6/29). Lybrel, which contains a lower dose of synthetic hormones in a daily dose than traditional oral contraceptives, is taken 365 days a year with no placebo pills. The usual regimen for oral contraceptives is 21 active pills taken consecutively, followed by seven placebo pills. During the week of placebo pills, women bleed and experience other menstrual symptoms. The period women experience during the week of placebo pills is a "withdrawal bleed," which is not necessarily the same as normal menstrual bleeding. According to Wyeth, Lybrel stopped 71% of women's bleeding after seven months. One study shows that almost all women who took the drug began experiencing their periods within three months of terminating its use (Kaiser Daily Women's Health Policy Report, 5/24).

Data Sought
According to the company, FDA is seeking packaging information and "stability" data that demonstrates whether the pill is able to remain on pharmacy shelves or in medicine cabinets for an extensive period of time without denaturing (Wall Street Journal, 6/29). Wyeth also must provide additional data from clinical trials on pregnancy rates, bleeding patterns and the discontinuation rates of participants enrolled in the trials, according to FDA (AP/San Diego Union-Tribune, 6/28). Amy Marren, a physician in Wyeth's global medical affairs division, said that "in some fashion, ... FDA intends to discuss" bleeding patterns among the women taking Lybrel, adding that the number of women taking Lybrel who stopped menstrual bleeding increased over time, though some women continued to experience bleeding or spotting. Marren also said that it is unclear why the agency wanted to review how many women stopped taking Lybrel during the trial (Dow Jones Newswires, 6/28). Wyeth said it is confident that it can answer the questions posed by FDA (Reuters, 6/29). FDA officials could not be reached for comment, according to Dow Jones Newswires (Dow Jones Newswires, 6/28).

More Than 80% of Women Taking Experimental Oral Contraceptive Eliminated Menstrual Bleeding, Study Says
More than 80% of women who took Wyeth's experimental oral contraceptive Anya, which can eliminate periods, reported total menstrual bleeding suppression after two years of regular use, according to a study presented on Monday at the Society of Obstetricians and Gynecologists of Canada's 62nd Annual Clinical Meeting in Vancouver, Canada, Toronto's Globe and Mail reports. Robert Reid, an ob-gyn professor at Queen's University, and colleagues examined 79 women who took Anya, which has not been approved by Canada's national health agency Health Canada. The drug has a lower dose of hormones than traditional birth control pills, according to the Globe and Mail. The researchers found that about 5% of the women enrolled in the study reported spotting or bleeding, and the pills had similar side effects to those of other oral contraceptives. Christine Derzko, an ob-gyn at St. Michael's Hospital in Toronto, said bleeding is not a physiological necessity for women taking oral contraceptives, and bleeding for some women can lead to "very serious medical (side effects)." However, Christine Hitchcock, a research associate at the Centre for Menstrual Cycle Ovulation Research at the University of British Columbia, said that the "lack of a break from hormonal stimulation" when taking oral contraceptives that can eliminate periods "is potentially a problem, not the lack of menstrual bleeding that occurs during the pill-free interval." She said that use of oral contraceptives could increase risk of developing cervical cancer, adding, "[N]obody's looked at the effects on breasts, nobody's looked at the effects on teenage development, breast density, bone density." According to the Globe and Mail, Health Canada and Wyeth are discussing studies to follow up with women taking Anya every six months to screen for any long-term effects of the drug's use (Gandhi, Globe and Mail, 6/27). Reid on Saturday while speaking on a panel at the SOGC meeting said a recent article in the journal Contraception showed that about 50% of women without severe menstrual cycle-related complications would prefer to suppress their periods (Lev, CP/Canada, 6/24).















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