If You Choose Ortho Evra, Consider This
Ortho Evra Has Serious Side Effects
The Ortho Evra patch is a thin, beige, plastic patch that sticks to the skin, delivering synthetic estrogen and progestin for a week. A new patch is placed on the skin of the buttocks, stomach, upper outer arm, or upper torso once a week for three weeks in a row. No patch is used in the fourth week.
Ortho Evra is a norelgestromin and ethinyl estradiol transdermal system, or to put it simply -- a birth control patch. Ortho Evra worn on the body and delivers a steady flow of hormones through the skin and into your bloodstream over a period of seven days. It is much simpler to use than other birth control methods; however there are serious risks associated with the use of Ortho Evra.
A September 20, 2006 FDA MedWatch Alert warned that the Ortho Evra label was being changed as a result of new data from two studies which were intended to quantify the risk of developing a serious blood clot in a woman using the Ortho Evra skin patch in comparison to that of a woman using a traditional birth control pill.
The first study suggested that the Ortho Evra skin patch does not cause a blood clot risk any higher than that present for a woman using a birth control pill. The second study, however, concluded that, in comparison to the pill, the Ortho Evra patch produces almost double the risk of developing serious blood clots, or venous thromboembolism (VTE).
In November 2005 the FDA approved a stronger warning about the blood clot risk associated with the birth control patch. The revised Ortho Evra label, or package insert, included a bolded warning which states that a woman who uses this contraceptive patch is exposed to about 60 percent more estrogen than if she was taking a typical birth control pill containing 35 micrograms of estrogen. It is widely believed that it is this increased level of estrogen that leads to the increased risk for blood clots.
Like most drugs, before the FDA could approve Ortho Evra, the product’s safety and efficacy had to be tested through clinical trials. During these trials, two women using the Ortho Evra patch developed blood clots that traveled to their lungs. Ortho McNeil did not wish to count these cases as possibly related to use of Ortho Evra because the patient had undergone surgery. Officials with the FDA however, disagreed strongly with the company’s assessment of these possible risks, stating that the incidence rates quoted in their findings may be misleading. The FDA recommended that reports of blood clots should be closely monitored once the patch was approved. No such monitoring for blood clots took place.
Starting in January 2006, Ortho Evra manufacturer Johnson & Johnson has been settling Ortho Evra lawsuits that involving the following serious side effects in women using their birth control patch:
- Heart Attacks
- Pulmonary Embolisms
- Deep Vein Thrombosis
More recently, on May 2, 2006 lawyers for Johnson & Johnson announced their "quick-settlement strategy" at conferences with the respective judge presiding over the federal court Ortho Evra cases and the New Jersey state court Ortho Evra cases.
Want to read more? Visit me at DrugInjuryLaw.com.
Ortho Evra Timeline
pre-2001: "...the company's own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent." NY Times 2002: FDA approves the Ortho Evra patch. TIME magazine hails the patch as one of the coolest inventions of 2002 writing, "Ortho-Evra Birth Control Patch: Small, waterproof and delivers the same amount of estrogen and progesterone as the pill." TIME
2003: Ortho McNeil refuses to fund a study comparing its patch to the pill because of "too high a chance that study may not produce a positive result for Evra" and, of course, the "risk that Ortho-Evra may be the same or worse than Ortho-Cyclen." USA Today
11/2005: FDA issues a public warning that the patch exposes women to 60 percent more estrogen than the pill. This warning came out "four months after The Associated Press reported that patch users die and suffer blood clots at a rate three times higher than women taking the pill," and "six years after the company's own study showed the high estrogen releases." USA Today and NY Times
2/2006: "A new study shows that women using the Ortho Evra birth-control patch have double the risk of developing blood clots compared with those who take the birth-control pill..." NY Times
4/2006: Johnson & Johnson begin settling lawsuits surrounding injuries and deaths due to its Ortho Evra patch.
9/2006: J&J finally revises the Package Insert for Ortho Evra to include for the first time a warning about the increased risk of venous thromboembolism. This new label, however, included conflicting information about that risk by mentioning two different study results concerning clotting risk. One study showed that patch users were twice as likely as birth control users to develop venous thromboembolism. The other study showed that patch users and pill users were equally likely to develop venous thromboembolism.
8/2007: The results from another later study that was done for J&J by the Boston Collaborative Drug Surveillance Program (BCDSP) regarding the safety profile of Ortho Evra -- the second such study done for J&J by BCDSP, to be precise -- showed that the odds of developing venous thromboembolism were, in fact, higher for women aged 15 - 44 who use the Ortho Evra patch than women using birth control pills.
1/2008: The FDA orders J&J to put the results of this second BCDSP study on the Ortho Evra patch label.
9/2008: Public Citizen's Health Research Group, a consumer advocacy organization, adds Ortho Evra to its ongoing list of dangerous medicines, warning that there is "no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives." CBS News
10/2008: The FDA approves another Ortho Evra warning label change which is based on new cases from the BCDSP studies regarding patch users' risk of venous thromboembolism.
What Does It Take For Convenience To Outweigh Risks?
In my regular routine of checking for news updates on Ortho Evra, I've noticed more and more comments being made about convenience versus risk. Where does one draw the line? There's no doubt about it, the Ortho Evra patch is convenient. There's no pill to remember, no scares when you miss a pill. Simply easy. But how do you decide when easy just isn't worth it.
In the past couple years there have been more and more incidents of injuries caused by the Ortho Evra patch, and, as a result, serious warning label changes. These risks range from deep vein thrombosis (DVT) in the extremities, pulmonary embolisms (PE) , to serious and life changing strokes. And these injuries aren't just befalling women who smoke, are overweight, or are over 35. These blood clots and strokes are affecting healthy young women.
One might reply that these are side effects that are present regardless of which birth control you use, and that is true. However, it is not as widely known that the risk for blood clots and strokes is actually higher with the Ortho Evra patch than for regular birth control pills. The reason for this is the method of dosage. Contraceptive pills are taken each day, thus all that is required to be effective is a small amount of estrogen and progestin. However, the patch is designed in such a way that it must last for 3 weeks. This means that its initial estrogen/progestin content is much higher, and the amount of medicine in your blood stream is a lot higher, too. When all is taken into account, the risk raises accordingly.
There are even multiple websites and articles popping up advising women on how to skip periods by forgoing their usual one week "break" a month from hormones. Thus far, scientists are unsure about how continuous hormone use might increase the risk for blood clots and strokes, though most suspect that increasing the body's intake of hormones like estrogen must also increase the risks that go along with this exposure.
Many doctors, most adamantly Dr. Leslie Miller, conclude that it is not unsafe to miss a period. However, they fail to make such claims about continuous hormone exposure. Whereas it may be safe to skip a period, it does not follow that continuous hormone exposure is a safe means by which to skip a period. From the organization Society for Menstrual Cycle Research:
----> "...further research on the potential health risks and long-term safety of cycle-stopping contraception is still needed."
----> "It is important to note that cycle-stopping contraceptives do not only reduce or eliminate menstrual bleeding, but also suppress the complex hormonal interplay of the menstrual cycle. The impacts of this cycle on women's health are not completely understood."
----> "Historically, nasty surprises with hormonal therapies for women (e.g...the link between oral contraceptives and blood clots, DES and various health problems) have taken many years to surface. Additionally, when any medication is evaluated for healthy women, the potential risks should be weighed more heavily than in situations when medication is considered to treat a disease."
All I am wondering here is, in our age of ease and convenience, so many things are left unevaluated. It's easy so we do it. It saves time, so we use it. Its fast, cheap, and on every corner, so we eat it. When it comes down to it, what does it take to put our health and lively-hood over convenience?
I don't have the answers, you tell me!
You Tell Me
Do the convenient benefits of the Ortho Evra patch outweigh the risk of serious side effects?See results without voting
In The News
An Ortho Evra Must-Read: The Bitterest Pill
January 21, 2009
I recently came across an excellent paper called, The Bitterest Pill: How Drug companies Fail To Protect Women And How Lawsuits Save Their Lives. If you have the time to read even just a little, I strongly suggest checking it out.
The injuries and subsequent lawsuits surrounding the Ortho Evra patch make up a large segment of this study into how lawsuits help to ensure the safety of pharmaceutical products designed specifically for women. I would like to briefly present some of the most interesting (and disturbing) parts of the Ortho Evra section for your information.
Johnson and Johnson really set the tone for the future of the Ortho Evra patch right from the start with its decision to hire Dr. Andrew Friedman. Dr. Friedman, who "had been fabricating 80 percent of patient data that he used in articles he had published in medical journals" and also "alter[ed] files in three studies of hormonal drugs for women" was hired to head the clinical trials and research for the patch. Yet, it was a convenient hire for J&J, as "its clinical trials seemed to get in the way." Who better to take care of that than an experienced inventor of "better" reports?
After applying a "correction factor" to the studies, "the correction was buried in a mathematical formula in a large report submitted to the FDA and '[w]hen the study was published in 2002, there was no reference to the alteration.' In 2002, the FDA approved the patch, which the company marketed falsely as releasing 20 micrograms of estrogen to the blood every 24 hours." The original results of the study showed 76 micrograms of estrogen.
Once the patch was on the market, the problems became even more clear. Women were popping up all over the country reporting clots and even deaths:
"The FOIA documents and subsequent news reports disclosed that since August 2002, the FDA had been aware there had been 17 deaths from heart attacks or strokes of patch users under the age of 30. Associated Press wrote, '[t]hough the Food and Drug Administration and patchmaker Ortho McNeil saw warning signs of possible problems with the patch well before it reached the market, both maintain that the patch is as safe as the pill. However, the reports obtained by the Associated Press appear to indicate that in 2004, when 800,000 women were on the patch, the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.'"
The paper goes on to point out that due to women's advocacy groups and lawsuits filed on behalf of injured women, Johnson and Johnson were, slowly but surely, forced to make label changes and release negative findings about their Ortho Evra patch.
In the subsequent sections of The Bitterest Pill, the authors go on to show how Ortho Evra does not stand alone in a long history of products developed specifically for women which have turned out to be dangerous and fatal. The main thrust of the paper is a commentary on the dangers of federal preemption.
Briefly, federal preemption for pharmaceutical companies would provide an immunity of sorts for products which have been approved by the FDA. This means that the consumers would no longer have the right to sue pharmaceutical companies for faulty and/or dangerous products. The point here is, without the threat of lawsuits, settlements, and public exposure, what would have motivated the manufacturers of Ortho Evra to finally give women the information necessary to make informed decisions about their contraception?
Once again, I would encourage you to read the paper yourself. Although somewhat lengthy, it is a quick read and would be of great interest to many.
Get the full paper here.
Getting The Coverage It Deserves: CBS Reports On Dangers Of Ortho Evra
December 12, 2008
In a report by CBS, the risks of the Ortho Evra birth control patch were given the attention they deserve. Not only did CBS post an in-depth article on their news website, but they also included a segment about Ortho Evra on their morning show, The Early Show. You can find a video of that segment here. It is refreshing to see that finally, after many years of slow changes to the warning label, the FDA and large public media is calling attention to what hundreds of unfortunate patch users have been saying since the beginning, the Ortho Evra patch is just not safe.
Although originally marketed as equally as safe as the birth control pill, Johnson and Johnson now admit what they knew all along. The patch contains 60% more estrogen than standard birth control pills, which means, "patch users die and suffer blood clots at a rate three times higher than women taking the pill... [About] a dozen women, most in their late teens and early 20s, died in 2004 from blood clots believed to be related to the birth-control patch, and dozens more survived strokes and other clot-related problems."
The problem is the way the estrogen is administered into the body. While pills go into the digestive tract, losing much estrogen and leaving the system within several hours, estrogen from the patch lingers much, much longer. As a result, patch users absorb 50% more estrogen than pill users. This is what increases their risk for blood clots.
The CBS report gets worse:
"In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was 'too high a chance that study may not produce a positive result for Evra' and there was a 'risk that Ortho Evra may be the same or worse than Ortho-Cyclen.'"
Basically, Johnson and Johnson turned away studies that may deem their product unsafe. From the Johnson and Johnson website, "Health advances matter. Our people are dedicated to creating a wide range of ideas, products and services that improve health and well-being." Seems like they are more dedicated to doing whatever it takes to get their products on the market and money into their pockets.
As a final note the CBS news report added, "In September, Public Citizen's Health Research Group, a consumer advocacy organization, added Ortho Evra to its ongoing list of dangerous medicines, warning that there is "no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives."
Please let us know what you think. Post a comment below.
Johnson & Johnson Updates Ortho Evra Warning Label October 2008: Are Even Greater Risks To Be Included?
November 6, 2008
Back in September of 2006, Johnson & Johnson revised their Package Insert for Ortho Evra to include a warning about the increased risk of venous thromboembolism, or VTE. Unfortunately, the warning was a little halfhearted.
The label mentioned two studies. One found that the risk for VTE was twice as high for patch users as compared to pill users. However, the other study maintained that the risks were equal. Yet, around August 2007 a further study by the Boston Collaborative Drug Surveillance Program (BCDSP) became available. This time the results of the first study were confirmed. Patch users are, in fact, at a greater risk for VTE than those women using contraceptive pills.
Finally, in January of 2008, the FDA ordered J&J to change its warning label to include these results. What took so long? It is disturbing that the FDA was so behind on ordering this revision, but even more disturbing is that J&J was not at all compelled to take measures on its own. J&J has a duty to ensure the Ortho Evra label reflects accurate and up-to-date information, and, further, a duty to keep its consumers safe.
Now, J&J is making label changes again. The FDA has just approved, on October 30, 2008, another Ortho Evra warning label change which is based on new cases from the BCDSP studies regarding patch users' risk of VTE. We can only guess what the new changes will reflect. Are the risks even higher than the label now claims? I suppose only time will tell.
If you see the new label or have anything at all to add, your comments are appreciated.
If You Are Hurt By Ortho Evra, You Might Not Be Able To Sue The Drug Company
In March 2008, I was interviewed by Mark Uehling at ClinPage.com to answer speculation about when the drug safety wars going on now with the FDA, the Supreme Court, and the pharmaceutical companies might end, if ever.
The outcome of an upcoming Supreme Court case, Wyeth v. Levine, will answer the issue of whether manufacturers of drugs should be sheltered from plaintiffs' lawsuits if the drug is approved by the FDA. If granted, this "federal preemption" would mean that most people injured by a drug would be prevented from filing a lawsuit.