SKYLA SIDE EFFECTS
- Generic Name: levonorgestrel-releasing intrauterine system
- Brand Name: Skyla
- Drug Class: Progestins
The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:
- Ectopic Pregnancy
- Intrauterine Pregnancy
- Group A Streptococcal Sepsis (GAS)
- Pelvic Inflammatory Disease
- Ovarian Cysts
- Bleeding Pattern Alterations
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 1 by SOC (presented as crude incidences).
Table 1: Adverse reactions that occurred in at least 1% of Skyla users in clinical trials by SOC
|System Organ Class||Adverse Reaction||Incidence (%) (N=1,672)|
|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/Seborrhea||13.6/1.4|
|Nervous System Disorders||Headache||12.4|
|Psychiatric Disorders||Depression/Depressed mood||3.8/0.5|
|a Ovarian cysts were reported as adverse events if they were abnormal, non-functional cysts and/or had a diameter >3 cm on ultrasound examination
b Not all bleeding alterations were captured as adverse reactions.
The following adverse reactions have been identified during post approval use of LNG-releasing IUSs. 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.
- Arterial thrombotic and venous thromboembolic events, including cases of pulmonary embolism, deep vein thrombosis and stroke
- Device breakage
- Hypersensitivity (including rash, urticaria, and angioedema)
- Increased blood pressure
SRC: NLM .