"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"...
- Clinician Information:
Skyla Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Skyla (levonorgestrel-releasing intrauterine system) is a contraceptive used to prevent pregnancy for up to 3 years. Common side effects can include bleeding, inflammation of the vulva or vagina, abdominal/pelvic pain, acne/dry skin, ovarian cysts, and headache.
Skyla is available as one sterile intrauterine system with a 13.5 mg levonorgestrel dose. Skyla must be removed or replaced after 3 years. Other drugs may interact with Skyla. Tell your doctor all medications you use. Patients should avoid grapefruit juice while using Skyla. Women who have a current pelvic infection, get infections easily, or have certain cancers should not use Skyla. Pregnancy while using Skyla is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Progestins, hormones found in Skyla, do pass into breast milk. No side effects of Skyla have been found to affect breastfeeding or the health, growth, or development of infants.
Our Skyla (levonorgestrel-releasing intrauterine system) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when using this device.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Skyla FDA Prescribing Information: Side Effects
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 entire FDA prescribing information for Skyla (Levonorgestrel-Releasing Intrauterine System) »
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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