Navigation Links
More Evidence Shows Newer Forms of 'Pill' Raise Clot Risk, FDA Says
Date:10/28/2011

THURSDAY, Oct. 27 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday said it "remains concerned" that a newer generation of birth control pills may raise the odds for serious blood clots more than older forms of the Pill.

The announcement concerns oral contraceptives containing a newer type of progestin hormone called drospirenone, which includes Bayer's Yaz or Yasmin. According to the FDA, the new study found a higher risk of venous thromboembolisms (VTEs) -- potentially dangerous clots -- in women on the drospirenone-containing pills vs. those on older forms of oral contraceptives.

The FDA-funded review involved the medical histories of more than 800,000 American women, all of whom were on some type of birth control between 2001 and 2008. The study found that women taking the newer oral contraceptives experienced a higher rate of clots than women on older forms of the contraceptive pill.

The review also found that women on two other forms of birth control -- the Ortho Evra patch from Johnson & Johnson and the NuvaRing vaginal ring from Merck -- had a higher rate of clots.

For now, the FDA is not advising that most women switch to another form of contraception. "If your birth control pill contains drospirenone, do not stop taking it without first talking to your health care professional," the agency said. "Contact your health care professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots."

Thursday's announcement was not the FDA's first word on this issue, nor is likely to be the last. The agency issued a similar warning in September, and in a statement released Thursday said that, "given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study," it plans to host a public meeting on the issue on Dec. 8.

The announcement Thursday comes a day after the release of a study in BMJ that also found newer birth control pills were tied to a higher risk for clots.

In that study, researchers reviewed data on all Danish women, aged 15 to 49, who were not pregnant between January 2001 and December 2009. During that time, more than 4,200 first episodes of VTEs occurred.

Women taking birth control pills with a newer progestin hormone had twice the risk of clots compared to those who took the older form of contraceptive pills.

Compared to women who did not use birth control pills, the risk of VTE was three times higher among those who used pills with levonorgestrel and six times higher among those who took pills with drospirenone, desogestrel or gestodene.

But the absolute risk of VTE associated with taking the newer pills remained relatively low, about 10 per 10,000 women, according to the University of Copenhagen researchers.

For every 2,000 women who switched from using newer pills to pills with levonorgestrel, there would be one less case of clots a year.

While some doctors may choose to prescribe birth control pills with a lower risk whenever possible, it is crucial not to exaggerate the risk of VTE, Dr. Philip Hannaford of the University of Aberdeen in Scotland, wrote in an accompanying editorial in the journal.

"Oral contraceptives are remarkably safe and may confer important long-term benefits in relation to cancer and mortality," he said in a journal news release.

Dr. Glenn Jacobowitz, vice chair of the division of vascular surgery at NYU Langone Medical Center in New York City, said: "The information for Yaz is not new. That has recently already been shown in studies to have an increased risk of blood clots than other oral contraceptives. The information on NuvaRing and Ortho Evra would be a new, but similar finding. This is certainly worrisome, particularly for women over age 35 and for smokers."

More information

The American College of Obstetricians and Gynecologists has more about birth control pills.

-- HealthDay staff

SOURCES: Oct. 27, 2011, statement, U.S. Food and Drug Administration; Oct. 26, 2011, BMJ, online; Glenn Jacobowitz, M.D., vice chair of the division of vascular surgery at NYU Langone Medical Center, New York City


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Hayes Announces Appointment Of Dr Susan Levine To The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC)
2. Evidence-based care and outcomes improve at Get With The Guidelines-Stroke hospitals
3. Researchers find further evidence linking Epstein-Barr virus and risk of multiple sclerosis
4. More Evidence That Swings in Blood Pressure Raise Stroke Risk
5. Cellular pathway could provide evidence of how cancer and obesity are linked
6. Palladians Distinguished Clinicians Present at APTAs National CSM Convention in San Diego on Evidenced Informed Management of Chronic Low Back Pain Without Surgery
7. Pew Applauds Federal Grant Program Supporting State Expansion of Evidence-Based Home Visitation
8. Elseviers Journal of Evidence-Based Dental Practice celebrates 10th year with special issue
9. Evidence-based medicine theory can be applied to frequent flying says US professor
10. No Evidence That Lithium Helps in ALS
11. UNC study offers first clinical evidence of anti-cancer drug triggering viral infection
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
More Evidence Shows Newer Forms of 'Pill' Raise Clot Risk, FDA Says
(Date:5/24/2016)... VA (PRWEB) , ... May 24, 2016 , ... Controlling ... smarter - with the launch of the Aquanta Water Heater Controller , a ... smart phone or web-enabled device. As the Nest thermostat does for HVAC systems, ...
(Date:5/24/2016)... WI (PRWEB) , ... May 24, 2016 , ... ... In Milwaukee , Out patient Services To Begin In June , Aloria Health, ... pleased to announce the opening of Aloria Milwaukee, its first treatment facility for ...
(Date:5/24/2016)... NJ (PRWEB) , ... May 24, 2016 , ... The ... that’s causing the problem. A common injury that’s often misunderstood, whiplash should be swiftly ... MD, a Harvard-trained, orthopedic spine surgeon at Atlantic Spine Center . , ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... successful implementation of protocols designed to reduce bleeding complications from percutaneous coronary intervention ... Angiography and Interventions (SCAI) in Orlando, FL, document a 40% reduction in risk-adjusted ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... Essette Dashboard, its highly anticipated, web-based software module. The cutting-edge feature provides ... “secret sauce”? Integration with Izenda’s self-service business intelligence solution and its analytics ...
Breaking Medicine News(10 mins):
(Date:5/23/2016)... 2016 Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today ... programs. The hands-on learning experience is a 12-week summer ... Fellowship and Internship programs bring ... and interns are provided optional housing free of charge ... at the Riverfront Residence Hall to foster communication and ...
(Date:5/23/2016)... May 23, 2016 Non-invasive diagnostic ... of multiple diseases; ,Technology to be presented at Yissum’s ... Yissum Research Development Company of the Hebrew University of ... research agreement with Aurum Ventures MKI, the technology investment arm ... a new diagnostic approach for early detection of multiple ...
(Date:5/22/2016)... May 23, 2016 DS ... anti-fibrotic and anti-inflammatory compound DS102 in chronic obstructive ... non-alcoholic steatohepatitis (NASH) patients. Recent DS ... in lung tissue and has bronchodilatory, anti-inflammatory and ... administration. The Company will publish further detail on ...
Breaking Medicine Technology: