"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"...
The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:
- Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
- Intrauterine Pregnancy [see WARNINGS AND PRECAUTIONS]
- Group A Streptococcal Sepsis (GAS) [see WARNINGS AND PRECAUTIONS]
- Pelvic Inflammatory Disease [see WARNINGS AND PRECAUTIONS]
- Bleeding Pattern Alterations [see WARNINGS AND PRECAUTIONS]
- Perforation [see WARNINGS AND PRECAUTIONS]
- Expulsion [see WARNINGS AND PRECAUTIONS]
- Ovarian Cysts [see WARNINGS AND PRECAUTIONS]
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.
The data described below reflect exposure to Skyla in 1,672 patients in two contraception studies, including 1,383 exposed for one year and 993 who completed the three year studies. The population was generally healthy, 18 to 40-year old females requesting contraception and predominately Caucasian (82.6%). The data cover more than 40,000 cycles of exposure. The frequencies of reported adverse drug reactions represent crude incidences.
Most common adverse reactions (occurring in ≥ 5% users) were increased bleeding (7.8%), vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%) and nausea (5.5%).
In the contraception studies, 18% discontinued prematurely due to an adverse reaction. The most common adverse reactions leading to discontinuation (in > 1% of users) were uterine bleeding complaints (4.6%), device expulsion (3.2%), acne/seborrhea (2.9%), abdominal pain (2.5%) dysmenorrhea/uterine spasms (2.0%) and pelvic pain (1.8%).
Other common adverse reactions (occurring in ≥ 1% users) by System Organ Class (SOC): The frequencies of adverse reactions observed in clinical trials are summarized in Table 3 by SOC (presented as crude incidences).
Table 3: Adverse reactions that occurred in at least
1% of Skyla users in clinical trials by SOC
|System Organ Class||Adverse Reaction||Incidence (%)
|Reproductive System and Breast Disorders||Vulvovaginitis||20.2|
|Increased bleeding b||7.8|
|Device expulsion (complete and partial)||3.2|
|Upper genital tract infection||1.4|
|Gastrointestinal Disorders||Abdominal pain/pelvic pain||12.7/6.2|
|Skin and Subcutaneous Tissue Disorders||Acne/Seborrhoea||13.6/1.4|
|Nervous System Disorders||Headache||12.4|
|Psychiatric Disorders||Depression/ Depressed mood||3.8/0.5|
|aOvarian cysts were reported as AEs if they were abnormal,
non-functional cysts and/or had a diameter > 3 cm on ultrasound examination
bNot all bleeding alterations were captured as adverse reactions [see WARNINGS AND PRECAUTIONS].
The following adverse reactions have been identified during post approval use of another LNG IUS. 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.
Read the Skyla (levonorgestrel-releasing intrauterine system) Side Effects Center for a complete guide to possible side effects
No drug-drug interaction studies have been conducted with Skyla.
Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the serum concentrations of progestins.
Some drugs or herbal products that may decrease the serum concentration of LNG include:
- St. John's wort
Significant changes (increase or decrease) in the serum concentrations of the progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.
Consult the labeling of all concurrently used drugs to obtain further information about interactions with Skyla or the potential for enzyme alterations.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/10/2013
Additional Skyla Information
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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