Ortho EVRA - Low-Dose Contraceptive Patch

About Estrogen

Estrogen is associated with certain side effects, such as breast tenderness, bloating/weight gain, nausea and vomiting. These side effects are believed to be related to the level of hormones delivered into the bloodstream, particularly with higher levels of estrogen. In some rare cases, high estrogen levels are thought to be linked with serious cardiovascular side effects in some women. Therefore, low doses of estrogen in hormonal contraception are desired. According to FDA product labeling, women using Ortho EVRA(R), the only marketed birth control patch, are exposed to about 60 percent more estrogen than if they were using typical low-dose birth control pills. Increased levels of estrogen may increase the risk of blood clots, which led the FDA to add warnings to Ortho EVRA's labeling.

Recently visited:
Nintendo Wi-Fi USB Connector (DS+Wii) Review

Mac Book Pro 2.16Ghz SSD 128GB(Super Talent) OSX 10.5

Danger! Blood clots might kill

Vice President Dick Cheney was diagnosed just in time. The late NBC News correspondent David Bloom died from it.

DVT, deep vein thrombosis, and its impact on public figures has seemingly created an awareness revival, particularly by Bloom's widow Melanie, now the spokeswoman for the Coalition to Prevent Deep-Vein Thrombosis.

"The statistics show that 2 million Americans will develop a DVT each year," she says. "Out of that, 600,000 will go on to develop the pulmonary embolism. Out of that number, 300,000 will be fatal.

"That's a lot more than AIDS and breast cancer combined every year in the U.S. The numbers are staggering."

What exactly is deep vein thrombosis and who is at risk?

There are two types of deep vein thrombosis, said Dr. Michael Ombrellino, a vascular surgeon with the Vein Institute of New Jersey in Morristown.

"There is major deep vein thrombosis which effects the veins in the lower extremities," he said. "And there is minor which affects the calf veins."

If left untreated, the clot can travel to the lungs and cause a pulmonary embolism, Ombrellino said.

Such was the case with Bloom, who had pre-existing risk factors such as long-haul flights, particularly the ones between New York and Kuwait. Restricted mobility, such as Bloom sleeping in a tank with his knees up to his chin, is another factor.

Bloom also suffered from dehydration, due to dwindling supply lines. Staying hydrated is necessary to keep the blood thin and circulation flowing, said Ombrellino.

Other risk factors include obesity, indirect effects of trauma and genetic predisposition.

"Some birth control can play a role and cancer -- any malignancy," he said.

In September the Food and Drug Administration updated the label on the Ortho Evra birth-control patch to reflect the results of a study that found women using the patch faced twice the risk of clots than did women on the pill.

Age-wise, DVT primarily effects the elderly, though in Bloom's case it was genetic predisposition combined with his lifestyle risk factors.

"That's what we learned when they did the autopsy ... we had no idea that David had a genetic predisposition, and that's the Factor V Leiden," Melanie Bloom said. "That's basically an inherited blood coagulant disorder. They say if you have three or more risk factors at any given time, you could be at risk for what happened to David, which was a fatal, pulmonary embolism, or PE. I also learned that those with this Factor V Leiden or other genetic predisposition only make up a very small percentage of the number of deaths in America each year."

DVT treatments can range from compression stockings to blood de-clotting drugs such as Cuminin or the implantation of an inferior vena cava filter.

"This is a special metallic cage that is inserted through the inferior vena cava (the large vein that carries de-oxygenated blood from the lower half of the body into the heart) and it filters clots from the lower extremities," Ombrellino said.

With the exception of unexplained swelling of the lower legs, DVT onset is relatively asymptomatic, said Ombrellino. The gold standard in DVT detection is a venus ultrasound.

"If you are having shortness of breath, tightening of the chest, basically what that means is that a blood clot has broken away, traveled to the lungs and is now a pulmonary embolism, which is exactly what happened with my husband," Melanie Bloom said. "He had pain in his leg, and then the pain went away, he was feeling great. He called me the morning of the day he died. He ... sounded upbeat, he wasn't limping and everything was good. They were going to make the push across the Baghdad border, and that night ... he abruptly collapsed to the ground and died. The clot had broken free, so his leg didn't hurt anymore. But it had made its way to his lungs.

Ortho Evra death

The OrthoEvra birth control patch has been linked to an increased risk of blood clots, heart attacks, strokes and pulmonary embolism - and even death. TheseOrthoEvra dangers can lead to serious complications for women and are potentially fatal.

Despite the increased risk when compared with traditional birth control pills, the manufacturer of Ortho Evera has argued that the ease of use justifies the danger. They claim that since the birth control is delivered through a skin patch which only needs to be changed weekly, the risk of pregnancy caused by missing a daily does of the pill is reduced. However, studies have shown that in real world use, the birth control patch is actually less effective at promoting continued use.

A study was reported by Reuters health in August 2006 indicating that women considered to be at a high risk of pregnancy are more likely to continue with use of the oral birth control pills than with the Ortho Evera birth control patch. The study was conducted by physicians at the University of Maryland School of Medicine in Baltimore. The researchers concluded that “those using the contraceptive patch were more likely to become pregnant and more likely to discontinue usage”. The continued use of birth control measures was significantly higher in pill users compared with patch users.

The study challenges the manufacturer’s claim that the birth control patch is more effective at reducing unwanted pregnancy. This is yet another reason that experts have called for the FDA to remove the birth control patch from the market.

In late September 2006, the manufacturers of the OrthoEvra added a warning regarding the increased risk of blood clots. This label change came years after the manufacturer was aware of the birth control patch dangers. Saiontz, Kirk & Miles represent victims who were injured by the patch side effects, as there were improper warnings of these dangers and users were unable to make an informed risk/benefit analysis before taking the medication.

How to prevent blood clots - re Ortho Evra

A recent study found that newer third generation birth control pills double your risk of contracting a potentially fatal blood clot compared to older birth control pills. The group that conducted the study called Public Citizens, stated their facts today to the FDA in hopes that newer birth control pills that contain synthetic progestin desogestrel will be removed from the market immediately.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, told HealthDay News, “"While the use of any type of combined oral contraceptive holds an increased risk of venous thrombosis (blood clots), third-generation birth-control pills double that risk without preventing pregnancy any more effectively than older pills do. Worse, the FDA has known since 1995 that these oral contraceptives were more dangerous but has allowed them to stay on the market for 12 years.”

Although the newer birth control that poses the risk does have a more severe warning label, few actually read and take the warnings seriously. Blood clots typically form in the legs, and then travel elsewhere throughout your body, causing a blockage of blood flow that could cause serious harm or death.

According to HealthDay, the Public Citizens petition stated “The FDA must ensure the well-being and safety of women in the U.S. and ban third-generation oral contraceptives containing desogestrel," the Public Citizen petition stated. Women should discuss with their doctors alternative methods of birth control, such as the second-generation oral contraceptives, and how to safely switch contraceptive methods."

The newer pills are more popular because users experience fewer side affects. Along with their petition to the FDA, the Public Citizens also have a informative video on youtube which talks about the many things you need to know about birth control.

Author: Cary Byrd

Ortho Evra Side Effects

Since the Ortho Evra patch was approved in 2001, there has been some concern over serious Ortho Evra side effects. The Ortho Evra birth control patch was prescribed to over two million women in 2004 alone, according to its manufacturer Ortho-McNeil. The most serious Ortho Evra side effects to raise concern in medical communities across the nation is news that the patch increases a woman''s risk of developing a blood clot.

In 2005, a media source publicized the conclusions from an Ortho Evra side effects study they conducted independent of medical experts. This news group analyzed FDA data about Ortho Evra side effects reports to conclude that the birth control patch triples a woman''s risk of developing a fatal blood clot. This group calculated that the risk of death from a birth control patch side effect blood clot was three per 200,000 women. The risk of fatal blood clot from the oral birth control pill comparatively is one death in 200,000 women.

Concern about this potentially deadly Ortho Evra side effects continues to be fueled by recent reports of deaths linked to use of this medication. The birth control patch has been blamed for the deaths of 23 women, including 17 women who died as result of blood clot complications. Many of these alleged victims of fatal Ortho Evra side effects complications were young and healthy women with no history of blood clots or other cardiovascular conditions.

In these young healthy women who died as a result of Ortho Evra side effects, many developed a rapid onset of symptoms before falling deathly ill. These Ortho Evra side effects symptoms included:

* severe headache
* vision problems
* vomiting
* and nausea.

The patient package insert from Ortho-McNeil states that a number of birth control patch side effects can occur with use of this medication. Many of these potential side effects are shared by all hormonal birth control methods. The possible Ortho Evra side effects risks include: breast changes, headaches, nausea, menstrual changes, vaginal discharge, and abdominal cramps and bloating.

Ortho-McNeil and other medical experts have claimed that the Ortho Evra side effects study distorts the facts and misleads the public into believing unproven statements. Of the 13,000 clinical trial participants in 103 studies, not a single woman has suffered a birth control patch side effect that resulted in blood clot or fatality. These pundits refute the argument that Ortho Evra side effects risks can lead to life-threatening blood clots and other cardiovascular injury.

ORTHO EVRA F.A.Q.

Here is what official ORTHO EVRA F.A.Q. says:

Are there any risks associated with ORTHO EVRA?

Serious as well as minor side effects have been reported with the use of the Patch. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke.

Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

Hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth. You will be exposed to about 60% more estrogen if you use ORTHO EVRA than if you use a typical birth control pill containing 35 micrograms (mcg) of estrogen.

In general, increased estrogen exposure may increase the risk of side effects. The risk of venous thromboembolic disease (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA compared with that of a birth control pill containing norgestimate and 35 mcg of estrogen. One study found a doubling of this risk and another study found no increased risk.

You should discuss with your healthcare professional whether ORTHO EVRA is a good method of contraception for you. The Patch does not protect against HIV or sexually transmitted diseases.

Ortho Evra birth control patch news

I gotta start by saying I love that little flying carefree chick in the Ortho Evra birth control patch logo.

Just looking at it brings me peace, so much peace, I could barely raise an eyebrow when reading the Media Post April 5 article that Johnson & Johnson has been buying domain names in a preemptive strike against the creation of websites that might draw negative attention to Ortho Evra. I might wonder why did I not have my peaceful head in the sand. According to MP:

A study from February 2006 showed that blood clot risk was doubled for women using the birth control patch versus oral contraceptives. In addition, women who use the patch are exposed to 60% more hormones than those who take birth control pills....

My, that would sound serious if I didn't have the blind confidence that hormonal contraception is safer than any malady known to women, particularly fetal parasites. Imagine my surprise, then, when reading J&J's 2006 annual report, filed with the SEC six weeks ago, to see 1500 lawsuits or liability claims have been filed against Ortho Evra to date (p. 89), making it J&J's most highly sued product!

And I'm shocked to read more should be expected! According to Lawyers and Settlements:

Legal experts predict causation in cases involving... the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a "signature disease," meaning a condition easily tied to the drug because it is rare....

Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs' attorneys that the company is willing to cut a deal.

Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.

The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.

Yet in its 2006 SEC report, J&J continued to tout Evra as "the first contraceptive patch approved by the FDA," and attributed "a significant decline in sales" due to "labeling changes and negative media coverage concerning product safety."

Nevertheless, I shall not allow my ignorant peace to be disrupted by safety concerns. And speaking of, I shall continue to repeat the false but really nice sounding abortion industry mantra, "abortion, so much safer than pregnancy!"

Whoops, pregnancy, did I say? My peace is wobbling. Yet I know I cannot become pregnant on the hormonal birth control! The makers tell me so, and they wouldn't lie! See here on the The Ortho Evra website:

Ortho Evra helps prevent pregnancy the same way birth control pills do: by preventing ovulation, which means that the ovary does not release an egg to be fertilized; by thickening the cervical mucus, which makes it more difficult for sperm to enter the uterus; and by changing the endometrium to reduce the chance of implantation.

Implantation of what, I would wonder if I weren't in my peaceful yoga fetal position.

Source: Jill Stanek