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.

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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