Plan B One-Step
"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Plan B One-Step
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.
Plan B One-Step (levonorgestrel tablet) 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 Plan B One-Step (levonorgestrel tablet) 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 Plan B One-Step 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 Plan B One-Step (levonorgestrel tablet) 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 Plan B One-Step (levonorgestrel tablet) 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 Plan B One-Step (levonorgestrel tablet) users.
Table 1 : Adverse Events in > 4% of Women, by % Frequency
|Most Common Adverse Events (MedDRA)||Plan B One-Step
N = 1359 (%)
|Heavier menstrual bleeding||30.9|
|Lower abdominal pain||13.3|
|Delay of menses ( > 7 days)||4.5|
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.
Abdominal Pain, Nausea, Vomiting
General Disorders and Administration Site Conditions
Nervous System Disorders
Reproductive System and Breast Disorders
Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain
Read the Plan B One-Step (levonorgestrel tablet) Side Effects Center for a complete guide to possible side effects
Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:
- St. John's wort
Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or the potential for enzyme alterations.
Drug Abuse And Dependence
Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of Plan B One-Step (levonorgestrel tablet) .
Read the Plan B One-Step Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 7/30/2009
Additional Plan B One-Step Information
Plan B - User Reviews
Plan B User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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