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warnings and cautions
5 WARNINGS AND PRECAUTIONS Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after taking My way should be evaluated for ectopic pregnancy. ( 5.1 ) My way is not effective in terminating an existing pregnancy. ( 5.2 ) Effect on menses: My way may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be considered. ( 5.3 ) STI/HIV: My way does not protect against STI/HIV. ( 5.4 ) 5.1 Ectopic Pregnancy Ectopic pregnancies account for approximately 2% of all 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 is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking My Way. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking My Way. 5.2 Existing Pregnancy My Way is not effective in terminating an existing pregnancy. 5.3 Effects on Menses Some women may experience spotting a few days after taking My Way. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception. If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy. 5.4 STI/HIV My Way does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs). 5.5 Physical Examination and Follow-up A physical examination is not required prior to prescribing My Way. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking My Way. 5.6 Fertility Following Discontinuation A rapid return of fertility is likely following treatment with My Way for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of My Way to ensure ongoing prevention of pregnancy.
6 ADVERSE REACTIONS The most common adverse reactions (≥10%) in clinical trials included heavier menstrual bleeding (31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), headache (10%), and dizziness (10%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact at or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. My Way was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the My Way group, and 1,377 women in the Plan B group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given My Way was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the My Way group and 1.4% in Plan B group were lost to follow-up. The most common adverse events (>10%) in the clinical trial for women receiving My Way included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of My Way users. Table 1. Adverse Events in > 4% of Women, by % Frequency Most Common Adverse Events (MedDRA) Heavier menstrual bleeding 30.9 Nausea 13.7 Lower abdominal pain 13.3 Fatigue 13.3 Headache 10.3 Dizziness 9.6 Breast tenderness 8.2 Delay of menses (> 7 days) 4.5 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Plan B (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders Abdominal Pain, Nausea, Vomiting General Disorders and Administration Site Conditions Fatigue Nervous System Disorders Dizziness, Headache Reproductive System and Breast Disorders Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain