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:6/27/2016)... ... 27, 2016 , ... TherapySites, the leading website ... Tennessee Counseling Association. This new relationship allows TherapySites to continue to ... adding exclusive benefits and promotional offers. , "TCA is extremely excited about this ...
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution ... the emergency ambulance transport experience for the millions of people who require these ... disrupted the taxi industry through the use of technology. Now, SmartEMS has put ...
(Date:6/26/2016)... PLAINSBORO, N.J. (PRWEB) , ... June 27, 2016 , ... ... same sources, yet in many ways they remain in the eye of the beholder, ... Oncology (EBO), a publication of The American Journal of Managed Care. For the full ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a ... can give their videos a whole new perspective by using the title layers ... Film Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and ... to be personalized through a fitness app. The fitness app plans to fix the two ... currently only offer a one size fits all type program , They don’t ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Mass. , June 24, 2016   ... Spaulding Rehabilitation Network,s Dean Center for Tick ... Physical Medicine and Rehabilitation, MIT Hacking Medicine, University ... for Innovation, today announced the five finalists of ... for Lyme disease.  More than 100 scientists, clinicians, ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June ... -based mobile pulmonary function testing company, is now able to ... devices developed by ndd Medical Technologies , Inc. ... done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ... , can get any needed testing done in the comfort of ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, ... less invasive and more durable cerebrospinal fluid treatments, ... funding.  The Series-A funding is led by Innova ... Fund, and other private investors.  Arkis, new financing ... instrumentation and the market release of its in-licensed ...
Breaking Medicine Technology: