FDA News

FDA approves Bayer IUD Kyleena

The FDA has approved Kyleena for the prevention of pregnancy for up to 5 years, according to a press release issued by the device's manufacturer.

Kyleena is an intrauterine system that contains 19.5 mg of levonorgestrel, a progestin hormone.

"Data show that the use of effective, long-acting birth control methods including intrauterine devices — or IUDs — have helped to reduce unintended pregnancies in the United States but we still have a long way to go," Anita L. Nelson, MD, professor and chair of obstetrics and gynecology at Western University of Health Sciences, said in the release. "Kyleena is highly effective at preventing pregnancy and may be an appropriate choice for women who want a low-dose, non-daily birth control method."

Kyleena will be available in October 2016.

In a clinical trial of 1,452 women aged 18 to 35 who received Kyleena, 38% completed 5 years of use.

The Pearl Index pregnancy rate was listed as the following:

  • 0.16 (95% CI, 0.02-0.58) in year one, based on 16,207 28-day cycles of exposure
  • 0.38 (95% CI, 0.1-0.96) in year two, based on 13,853 28-day cycles of exposure
  • 0.45 (95% CI, 0.12-1.15) in year three, based on 11,610 28-day cycles of exposure
  • 0.15 (95% CI, 0.00-0.85) in year four, based on 8,556 28-day cycles of exposure
  • 0.37 (95% CI, 0.04-1.33) in year five, based on 7,087 28-day cycles of exposure

The cumulative 5-year Kaplan-Meier pregnancy rate was 1.45 (95% CI, 0.82-2.53) based on 57,313 28-day cycles of exposure.

Bayer reported that 22% of women discontinued use due to an adverse reaction. The most common adverse reactions were increased bleeding, breast pain or discomfort, dysmenorrhea or uterine spasm, acne or seborrhea, headache or migraine, abdominal or pelvic pain, ovarian cyst and vulvovaginitis.

The FDA has approved Kyleena for the prevention of pregnancy for up to 5 years, according to a press release issued by the device's manufacturer.

Kyleena is an intrauterine system that contains 19.5 mg of levonorgestrel, a progestin hormone.

"Data show that the use of effective, long-acting birth control methods including intrauterine devices — or IUDs — have helped to reduce unintended pregnancies in the United States but we still have a long way to go," Anita L. Nelson, MD, professor and chair of obstetrics and gynecology at Western University of Health Sciences, said in the release. "Kyleena is highly effective at preventing pregnancy and may be an appropriate choice for women who want a low-dose, non-daily birth control method."

Kyleena will be available in October 2016.

In a clinical trial of 1,452 women aged 18 to 35 who received Kyleena, 38% completed 5 years of use.

The Pearl Index pregnancy rate was listed as the following:

  • 0.16 (95% CI, 0.02-0.58) in year one, based on 16,207 28-day cycles of exposure
  • 0.38 (95% CI, 0.1-0.96) in year two, based on 13,853 28-day cycles of exposure
  • 0.45 (95% CI, 0.12-1.15) in year three, based on 11,610 28-day cycles of exposure
  • 0.15 (95% CI, 0.00-0.85) in year four, based on 8,556 28-day cycles of exposure
  • 0.37 (95% CI, 0.04-1.33) in year five, based on 7,087 28-day cycles of exposure

The cumulative 5-year Kaplan-Meier pregnancy rate was 1.45 (95% CI, 0.82-2.53) based on 57,313 28-day cycles of exposure.

Bayer reported that 22% of women discontinued use due to an adverse reaction. The most common adverse reactions were increased bleeding, breast pain or discomfort, dysmenorrhea or uterine spasm, acne or seborrhea, headache or migraine, abdominal or pelvic pain, ovarian cyst and vulvovaginitis.