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Blog (17)

Certain Birth Control Pills May Carry Higher Blood Clot Risk: FDA

Posted 10 Apr 2012 by Drugs.com

TUESDAY, April 10 – 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 new labels. The U.S. Food and Drug Administration said the updated labels will inform users that the pills – which include products such as Bayer's Yaz or Yasmin – may carry as much as a tripled risk for blood clots compared to birth control pills containing other types of progesterone (also called progestins) such as levonorgestrel. The agency findings came from observational studies, some of which found increased risk for blood clots while others did not, the FDA noted in its medication safety alert. The decision follows recommendations made in December by an FDA-appointed panel that several drospirenone-containing contraceptives carry revised labels ... Read more

FDA Medwatch Alert: Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

Posted 10 Apr 2012 by Drugs.com

ISSUE: FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills.Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. BACKGROUND: Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills. The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk ... Read more

FDA Panel Wants More Risk Information on Yaz Pills

Posted 9 Dec 2011 by Drugs.com

ADELPHI, Md. (AP) - Federal health experts said Thursday that drug labeling for Yaz and other widely-used birth control pills should be updated to emphasize recent data suggesting a higher risk of blood clots with the drugs than older contraceptive pills. The Food and Drug Administration's panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and needs more information about the potential risk of blood clots in the legs and lungs. Yaz, its predecessor Yasmin and related prescriptions use a manmade hormone called drospirenone, which mimics the naturally occurring female hormone progesterone. Approved in 2006, Yaz grew into the best-selling birth control pill in the U.S. by 2008, backed by hundreds of millions of dollars in TV and magazine advertising that emphasized its ability to clear up acne and other hormonal side effects. But ... Read more

FDA Medwatch Alert: Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

Posted 27 Oct 2011 by Drugs.com

[UPDATED 10-27-2011] FDA notified healthcare professionals of release of the final report of the FDA-funded study that evaluated the risk of blood clots in users of several different hormonal contraceptives. The link is provided below. FDA’s review of the results of this study, specifically those results related to drospirenone-containing birth control pills, will be presented and discussed at the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. [UPDATED 09/26/2011] FDA has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills. FD ... Read more

More Evidence Shows Newer Forms of 'Pill' Raise Clot Risk, FDA Says

Posted 27 Oct 2011 by Drugs.com

THURSDAY, Oct. 27 – 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 ... Read more

Related support groups: Birth Control, Contraception, Yasmin, NuvaRing, Ocella, Yaz, Ortho Evra, Apri, Kariva, Beyaz, Gianvi, Reclipsen, Desogen, Safyral, Ortho-Cept

Newer 'Pill' May Raise Blood Clot Risk

Posted 26 Oct 2011 by Drugs.com

WEDNESDAY, Oct. 26 – Birth control pills with newer types of progestogen hormones (drospirenone, desogestrel or gestodene) are more likely than others to cause serious blood clots, a new study confirms. These new pills – marketed as Yaz or Yasmin, among other brand names, in North America – are popular, although the risk of serious blood clots, also known as venous thromboembolism (VTE), has been noted before. Last month, the U.S. Food and Drug Administration issued a cautionary note warning of raised odds for blood clots in women taking the newer form of oral contraceptives. In the new study, researchers reviewed data on all Danish women, ages 15 to 49, not pregnant between January 2001 and December 2009. During that time, over 4,200 first episodes of VTEs occurred. Women taking birth control pills with a newer progestogen hormone had twice the risk of VTE compared to those who took ... Read more

Related support groups: Birth Control, Contraception, Yasmin, Ocella, Yaz, Apri, Kariva, Beyaz, Gianvi, Reclipsen, Desogen, Safyral, Ortho-Cept, Mircette, Angeliq

FDA Medwatch Alert: Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

Posted 1 Jun 2011 by Drugs.com

ISSUE: FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to ... Read more

Newer 'Pill' Linked to Higher Risk of Blood Clots

Posted 23 Apr 2011 by Drugs.com

THURSDAY, April 21 – Newer forms of birth control pills may carry a higher risk of serious blood clots than earlier oral contraceptives. Women taking the "fourth generation" pills containing drospirenone, a new type of progestogen hormone, had double to triple the risk of blood clots compared to women taking levonorgestrel-containing pills, according to two studies published online April 22 in BMJ. "This is confirming what a lot of physicians had suspected for some time. The new pills do have a higher clot risk. But it's still much lower than the risk associated with pregnancy, so it doesn't preclude us using it," said Dr. Rachel Bonnema, assistant professor of internal medicine at the University of Nebraska Medical Center in Omaha. Added Dr. Steven R. Goldstein, professor of obstetrics and gynecology at NYU Langone Medical Center in New York City: "Even if the findings turn out to be ... Read more

Newer Versions of the Pill Pose No Added Risk to Gallbladder

Posted 21 Apr 2011 by Drugs.com

WEDNESDAY, April 20 – The risk of gallbladder disease is similar for women taking either newer or older types of birth control pills, a new study finds. Recently, there have been concerns about a possible link between a fourth-generation progestin called drospirenone (marketed as Yaz or Yasmin in North America) and gallbladder disease, even though there are no published clinical studies on such an association. Drospirenone is one of the most popular types of birth control pills in North America. In this new study, researchers followed more than 2,700,000 women who used birth control pills containing ethinyl estradiol and a progestin continuously for at least six months. There was no clinically significant difference in the risk of gallbladder disease among women taking different types of birth control pills, including those with drospirenone. Reporting bias may be the reason for why ... Read more

Estrogen-Only Hormone Therapy May Reduce Breast Cancer Risk for Some

Posted 9 Dec 2010 by Drugs.com

THURSDAY, Dec. 9 – In a finding that seems to counter the prevailing wisdom that any form of hormone replacement therapy raises the risk of breast cancer, a new look at some old data suggests that estrogen-only hormone therapy might protect a small subset of postmenopausal women against the disease. "Exogenous estrogen [such as hormone therapy] is actually protective" in women who have a low risk for developing breast tumors, said study author Dr. Joseph Ragaz, a medical oncologist and clinical professor in the School of Population & Public Health at the University of British Columbia in Vancouver. With his colleagues, Ragaz took another look at data from the Women's Health Initiative (WHI) study, a national trial that has focused on ways to prevent breast and colorectal cancer, as well as heart disease and fracture risk, in postmenopausal women. The team planned to present its ... Read more

Study Shows HRT Even Riskier Than Thought

Posted 19 Oct 2010 by Drugs.com

TUESDAY, Oct. 19 – Not only does prolonged use of hormone replacement therapy raise the risk of breast cancer, new research finds, but it also ups the risk for more severe forms of the disease and increases a woman's chances of dying. A study appearing in the Oct. 20 issue of the Journal of the American Medical Association is at odds with previous observational studies that had suggested a raised risk of breast cancer, but only for less aggressive and more treatable tumors. The researchers added that this is the first time an increase in mortality has been shown. The findings apply only to estrogen-plus-progestin, or combined hormone therapy, not estrogen-alone therapy. "It looks like all categories of breast cancer are increased," said study author Dr. Rowan Chlebowski. "The preponderance of observational studies had suggested that the cancers would have a more favorable outcome but ... Read more

Estrogen Therapy May Be Linked to Kidney Stones

Posted 11 Oct 2010 by Drugs.com

MONDAY, Oct. 11 – Estrogen therapy may increase the risk of kidney stones in postmenopausal women, a new study suggests. For the study, researchers examined data on postmenopausal women in the United States, gathered from two trials in the Women's Health Initiative study. One trial included 10,739 women who had had a hysterectomy, and who received either an estrogen-only treatment or placebo, and were followed for an average of 7.1 years. The other included 16,608 women without hysterectomy who received either estrogen plus progestin therapy or placebo, and who were followed for an average of 5.6 years. There were 335 cases of kidney stones reported among women in the treatment groups and 284 cases among those in the placebo groups, the investigators found. The annual kidney stone incidence rate per 10,000 women per year was 39 in the treatment groups and 34 in the placebo groups, ... Read more

Weight a Factor in Breast Cancer Risk After HRT Use

Posted 10 Aug 2010 by Drugs.com

TUESDAY, Aug. 10 – Another analysis of data on hormone therapy use among U.S. women finds that the panorama of risks is even more complex than previously thought: Thinner women taking it showed a higher risk of developing breast cancer than heavier women. The California researchers also found that the longer a woman used either estrogen-alone therapy or estrogen-plus-progestin therapy, the higher the risk of disease. Similar results were seen for women who used combined therapy continuously rather than taking breaks during the month. "This gives us a clear correlation between the length of treatment and risk," said Dr. Freya Schnabel, director of breast surgery at NYU Langone Medical Center in New York City. "Ad hoc, people had made the assumption that, for the most part, shorter was better, but this definitely gives you some parameters on that." Given that current recommendations on ... Read more

With Hormone Therapy, Tender Breasts May Signal Cancer Risk

Posted 16 Jul 2010 by Drugs.com

MONDAY, Oct. 12 – Breast tenderness in women taking estrogen/progestin hormone replacement therapy could signal increased chances of developing breast cancer, a new study says. Women taking estrogen plus progestin who reported developing breast tenderness after starting the hormone therapy were 48 percent more likely to develop invasive breast cancer than women on hormone therapy who did not experience breast tenderness. Researchers said more study is needed before they would recommend that women who experience this symptom discontinue taking the hormones. But women who develop breast tenderness might want to reassess if the hormones are really necessary to control their menopausal symptoms. "It's too soon to tell women to quit their hormone therapy, but it is something for women to think about in balancing the risks versus the benefits," said the study's lead author, Dr. Carolyn J. ... Read more

Low-Dose HRT Patch May Lessen Stroke Risk

Posted 4 Jun 2010 by Drugs.com

FRIDAY, June 4 – Getting low-dose hormone replacement therapy through a skin patch may reduce a woman's risk for stroke, but high-dose patches could actually raise the risk, a new study suggests. Many women take hormone therapy to treat menopausal symptoms, but some studies have linked the treatment to an increased risk for stroke. For the new study, researchers reviewed a British database of medical records from 1987 and 2006, focusing on 15,710 cases in which a woman between the ages of 50 and 79 had a stroke. They compared the women with 59,958 other women. Women who used low-dose patches were at no greater risk for stroke than were women who didn't use patches, the study found, but use of high-dose patches upped the odds of stroke by 88 percent. Taking hormone therapy orally, meanwhile, increased the risk by 25 to 30 percent, compared with the risk for women who didn't take hormone ... Read more

Drospirenone/Estradiol Blog

Blog (17)

Certain Birth Control Pills May Carry Higher Blood Clot Risk: FDA

FDA Medwatch Alert: Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

FDA Panel Wants More Risk Information on Yaz Pills

FDA Medwatch Alert: Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

More Evidence Shows Newer Forms of 'Pill' Raise Clot Risk, FDA Says

Newer 'Pill' May Raise Blood Clot Risk

FDA Medwatch Alert: Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

Newer 'Pill' Linked to Higher Risk of Blood Clots

Newer Versions of the Pill Pose No Added Risk to Gallbladder

Estrogen-Only Hormone Therapy May Reduce Breast Cancer Risk for Some

Study Shows HRT Even Riskier Than Thought

Estrogen Therapy May Be Linked to Kidney Stones

Weight a Factor in Breast Cancer Risk After HRT Use

With Hormone Therapy, Tender Breasts May Signal Cancer Risk

Low-Dose HRT Patch May Lessen Stroke Risk

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