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warnings
WARNINGS Next Choice TM is not recommended for routine use as a contraceptive. Next Choice TM is not effective in terminating an existing pregnancy. Effects on Menses Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for postcoital and emergency contraceptive use. Some women may experience spotting a few days after taking Next Choice TM . At the time of expected menses, approximately 75% of women using Next Choice TM had vaginal bleeding similar to their normal menses, 12% to 13% bled more than usual, and 12% bled less than usual. The majority of women (87%) had their next menstrual period at the expected time or within ± 7 days, while 13% had a delay of more than 7 days beyond the anticipated onset of menses. If there is a delay in the onset of menses beyond 1 week, the possibility of pregnancy should be considered. Ectopic Pregnancy Ectopic pregnancies account for approximately 2% of reported pregnancies (19.7 per 1,000 reported pregnancies). Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. A history of ectopic pregnancy need not be considered a contraindication to use of this emergency contraceptive method. Health providers, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of ower abdominal pain after taking Next Choice TM .
ADVERSE REACTIONS The most common adverse events in the clinical trial for women receiving Next Choice TM included nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), and menstrual changes. The table below shows those adverse events that occurred in ≥5% of Next Choice TM users. Table 3 Adverse Events in ≥5% of Women, by % Frequency Most Common Adverse Events levonorgestrel N=977 (%) Nausea 23.1 Abdominal Pain 17.6 Fatigue 16.9 Headache 16.8 Heavier Menstrual Bleeding 13.8 Lighter Menstrual Bleeding 12.5 Dizziness 11.2 Breast Tenderness 10.7 Other complaints 9.7 Vomiting 5.6 Diarrhea 5.0 Next Choice TM demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events: Nausea: Occurred in 23% of women taking Next Choice TM (compared to 50% with Yuzpe) Vomiting: Occurred in 6% of women taking Next Choice TM (compared to 19% with Yuzpe)