Bayer receives FDA approval for long-term contraceptive

January 11, 2013
Bayer receives FDA approval for long-term contraceptive
Bayer HealthCare has received approval from the U.S. Food and Drug Administration for its new low-dose levonorgestrel-releasing intrauterine system called Skyla, according a Jan. 10 news release issued by the company.

(HealthDay)—Bayer HealthCare has received approval from the U.S. Food and Drug Administration for its new low-dose levonorgestrel-releasing intrauterine system (IUS) called Skyla, according a Jan. 10 news release issued by the company.

Bayer describes Skyla as a small, flexible plastic T-shaped device containing 13.5 mg of the hormone levonorgestrel. The 28 mm × 30 mm Skyla T-body is put in place through a 3.8 mm-diameter tube. A slow, low dose of is locally released in the uterus, with only small amounts of the hormone entering the bloodstream. The IUS prevents pregnancy for up to three years.

The regulatory approval of Skyla was based on data from a multi-national, randomized open-label Phase 3 trial of 2,884 women (aged 18 to 35 years), in which 1,432 women received Skyla. The IUS was 99 percent effective in preventing pregnancy and was well tolerated with no unexpected . There were low incidences of ectopic pregnancy, , expulsion of the device from the uterus, and uterine perforation.

"The approval of Skyla in the United States highlights Bayer's continued commitment to drive innovation and empower women with a variety of birth control options at different reproductive stages of their lives," Kemal Malik, M.D., Bayer's head of global development, said in a statement.

Explore further: EU approves Bayer's new long-term contraceptive: firm

More information: More Information

Related Stories

EU approves Bayer's new long-term contraceptive: firm

December 5, 2012
German drug maker Bayer said on Wednesday that European Union authorities had given the go-ahead for a new contraceptive which can prevent pregnancies for up to three years.

ACOG: Intrauterine device insertion linked to weight loss

May 7, 2012
(HealthDay) -- Women who undergo postpartum or interval insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) or Copper T 380A (CU-T) intrauterine devices experience weight loss in the two years following insertion, ...

FDA ties newer birth control drugs to blood clots

October 27, 2011
(AP) -- Safety concerns with the popular birth control pill Yaz increased Thursday as federal health scientists reported that the Bayer drug and other newer birth control treatments appear to increase the risk of dangerous ...

Consider IUDs for contraception, other conditions

April 13, 2012
Researchers at the University of Cincinnati (UC) have found that intrauterine devices (IUDs) containing progesterone are a safe and effective means of birth control and support its use as a treatment option for medical conditions ...

Certain birth control pills may carry higher blood clot risk: FDA

April 10, 2012
(HealthDay) -- U.S. health officials announced Tuesday that birth controls pills containing drospirenone -- a man-made version of the hormone progesterone -- may be associated with a higher risk of blood clots and will require ...

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.