Ortho Evra: News And Information

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.

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:

• Strokes


• 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.

For more information on Ortho Evra, you may also wish to visit my law firm's web site, www.DrugInjuryLaw.com. In the alternative, you may also submit a confidential free case evaluation.



Back to Quick Look At Contents

Photo courtesy of Kmye on Flickr.com

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.

12/2009: Ortho Evra changes its label again, this time to include some new additions to the contraindications, precautions, adverse reaction, and even the patient label. The new label notes that if you have any condition that causes your blood to clot more easily, you should not use Ortho Evra.

The problem with this latest addition is that most women would never know that they have a thrombophilic condition, such as Factor V Leiden. Most women discover that they are more prone to clotting after they have suffered a potentially fatal blood clot, stroke, or heart attack. Perhaps contraceptives such as Ortho Evra, NuvaRing, YAZ, Yasmin, and Ocella, which are associated with a higher risk of thromboembolisms (blood clots which have the potential to move to other parts of the body), should require a simple blood test such that the prescribing doctor is in a position to prescribe a birth control method which is truly the best option for their patient.

Back to Quick Look At Contents

Upper photo courtesy hellotulla at Flickr.com

Drug litigation law firm will review your potential Ortho Evra case if you submit a free online Case Evaluation which is strictly confidential and with no obligation.

The information you provide on this Free Case Evaluation will be treated as strictly confidential. You will get a reply no later than the next business day. Submitting a case evaluation does not obligate you to hire the law firm for your lawsuit. Cases are handled on a contingency fee basis, which means that you will make no payment for legal services until after the case is successful in getting legal compensation for you.

Back to Quick Look At Contents

In 1960 the FDA approved the first ever hormonal contraceptive, the birth control pill. Engendered by Margaret Sanger, founder of Planned Parenthood, strongly believed that only in ideal circumstances should a man and woman conceive. The pill was her idea to help families wait and time conception for that perfect moment. Although Sanger's motives have been considered less than ethical, and often downright racist, her vision did lead to the sexual empowerment of women the world over.

Since that time there have been many "advancements". We now have the patch, the ring, IUDs, birth control pills which help with acne and premenstrual disorders, and pills which even allow a woman to skip her period for months or even years. What the pill can do, and allows women to do, has come a long way. But how far have advancements in safety come?

Only two years after Enovid, the first contraceptive pill to receive FDA approval, hit the markets, their were numerous reports of safety issues. Most were related to blood clotting:

"There were reports of blood clots, strokes --and possible links to cancer. As early as 1962, the manufacturer of the birth control pill Enovid, G.D. Searle and Company, received reports of 132 cases of blood clots in Pill users. Eleven of the cases resulted in death. Searle maintained that there was no conclusive proof that the Pill caused those deaths, and the FDA assured doctors the drug was safe." (PBS.org)

The incidents only grew. Now, with the advent of more "convenient" birth control choices such as Ortho Evra and NuvaRing, and birth control pills that "go beyond" such as antiandrogenic pills like YAZ, Yasmin, and Ocella, the safety issues associated with these new combination contracptives are reaching the mainstream media, and therefore, the public.

Interestingly enough, study after study has shown that the older hormonal contraceptives containing ethinyl estradiol and levonorgestrel, are the safest. The controversy now remains: why are these new progestins, such as drospirenone (in YAZ, Yasmin, and Ocella) and etonogestrel (found in NuvaRing), which appear to have more risk for thromboembolisms, allowed to remain on the market?

If there is a safe effective hormonal contraceptive available, why does the FDA continue to allow these new formulations? The ability to prevent pregnancy is not changing with these contraceptives, but the safety aspect is. Hormonal contraceptives appear to be increasingly dangerous. Where are the safety innovations? Rather than pouring money into research which might make hormonal contraceptives safer, pharmaceutical companies want products which are more convenient and have more uses, making them more money.

Earlier this year, I wrote a summary of a paper entitled "The Bitterest Pill" which examines these very issues. Perhaps it is worth taking another look in light of hormonal contraceptives' 50th birthday.

For more information on Ortho Evra, you may also wish to visit my law firm's web site, www.DrugInjuryLaw.com. In the alternative, you may also submit a confidential free case evaluation.

Back to Quick Look At Contents

Will Bayer's New Patch Suffer The Same Fate As Ortho Evra?
June 15, 2009

Bayer Schering, manufacturer of the questionable birth control pills YAZ and Yasmin, is entering the final stages of trials for a new contraceptive patch. They seek to release the patch in 2012.

This new patch will contain a "third generation" progestin: gestodene. This is one of the third generation progestins that practitioners around the globe are being warned against prescribing. From the article "Effect of CSM's warning about safety of third generation oral contraceptives" in the British Medical Journal:

"On 18 October last year the Committee on Safety of Medicines issued its latest
warning on the risk of thromboembolism associated with combined oral contraceptives. It did this after becoming aware of three studies indicating that combined oral contraceptives containing desogestrel and gestodene were likely to be associated with around a twofold increase in the risk of thromboembolism when compared with those containing other progestogens."

And again in an editorial by the British Medical Journal:

"These studies--an international study organised by the World Health Organisation; the European transnational study of oral contraceptives, which is funded by the pharmaceutical company Schering AG; and a study of data from the United Kingdom general practice research database (formerly known as VAMP)--were designed to examine whether the risk of vascular disease in women taking the newer oral contraceptive pills differed from that in women taking the slightly older pills containing predominantly the progestogen levonorgestrel. Analysis of data from the completed WHO study and interim analyses of the other studies' data suggest that the risk of venous thrombosis (mainly deep vein thrombosis of the leg) was approximately doubled in women taking the newer pills."

Doesn't it seem odd that Bayer would consider manufacturing a product that doctors are already discouraged from prescribing?

Let me know what you think. Leave a comment below.

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.

Back to Quick Look At Contents

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 half hearted.

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.

What If You Were Hurt By Ortho Evra And Couldn't Sue?
It May Soon Happen

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 the November 3, 2008 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. What do you think?

Read about the future of drug injury lawsuits on DrugInjuryWatch. >>

Back to Quick Look At Contents

What Are They?

Pulmonary embolism, commonly referred to in the medical community as PE, is a highly dangerous, life threatening condition.

From WebMD:
"Pulmonary embolism is the sudden blockage of a major blood vessel (artery) in the lung, usually by a blood clot. In most cases, the clots are small and are not deadly, but they can damage the lung. But if the clot is large and stops blood flow to the lung, it can be deadly. Quick treatment could save your life or reduce the risk of future problems."

Many times a PE is associated with a deep vein thrombosis (DVT), a blood clot which forms in a vein of the deep venous system. This type of blood clot can occur anywhere in the body, but they usually happen in extremities, like the leg. According to WebMD, "Among patients with DVT, pulmonary embolism will occur in 30%." This occurs because the blood clot makes its way to the lung, where very serious damage can occur.

What Are The Symptoms?

Often there are no symptoms of DVT. In fact, WebMD reports that over half of DVT cases showed no signs. However, if you do experience any of the symptoms listed below, seek medical care immediately. A DVT can quickly become a life threatening pulmonary embolism.

• Deep Vein Thrombosis
  
  
  
  • Swelling in one or both legs
    
  • Pain or tenderness in one or both legs, which may occur only while standing or walking
    
  • Warmth in the skin of the affected leg
    
  • Red or discolored skin in the affected leg
    
  • Visible surface veins
    
  • Leg fatigue
    

Although DVTs are most often the precursor to PE, don't expect a gradual onset beginning with the symptoms listed above. A pulmonary embolism can come on quickly and without warning. For that reason WebMD says that if you think you may have pulmonary embolism, call your doctor or go to the emergency room at the nearest hospital. Watchful waiting is not appropriate for pulmonary embolism.

• Pulmonary Embolism
  
  
  
  • Shortness of breath that may occur suddenly.
    
  • Sudden, sharp chest pain that may become worse with deep breathing or coughing.
    
  • Rapid heart rate.
    
  • Rapid breathing.
    
  • Sweating.
    
  • Anxiety.
    
  • Coughing up blood or pink, foamy mucus.
    
  • Fainting.
    
  • Heart palpitations.
    
  • Signs of shock.
    

Treatment and Recovery

Normally once the PE or DVT (or both) has been diagnosed, the first step is to dissolve the blood clot. From WebMD:

"If symptoms are severe and life-threatening, immediate and sometimes aggressive treatment is needed. Aggressive treatment may include thrombolytic medicines, which can dissolve a blood clot quickly but also increase the risk of severe bleeding. Another option for life-threatening, large pulmonary embolism is surgical removal of the clot, called an embolectomy. This surgery is only available at a few large hospitals."

The next step is to prevent future clotting. This involves anticoagulation medication which must be taken for several months. For an unfortunate few, it must be taken forever. All hormone therapy must be stopped (this includes any hormonal birth control methods) and if pregnancy occurs, a series a regular shots must be given to prevent clot formation.

Recovery

Recovering from pulmonary embolism can be a long and painful process. An excellent and informative source for recovery information from someone who has experienced, and recovered from, a PE has a great website over on HubPages.com. It is called Recovering From A Pulmonary Embolism.

Another avenue to connect with others and learn about the recovery process is through support groups. DailyStrength.org has a pulmonary embolism support group geared to open the lines of communication for PE sufferers everywhere.

Back to Quick Look At Contents

Illustration copyright 2000 by Nucleus Communications, Inc. All rights reserved. http://www.nucleusinc.com