Ortho Evra Birth Control Patch Information

 

 

FDA ORTHO EVRA UPDATE: January 21, 2008.

The FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.

FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#orthoevrapatch

 

Deaths from blood clots, stokes, and death associated with Ortho Evra.

By November 2005, there were 23 deaths associated with Ortho Evra, of which 17 were directly related to blood clots. On November 11, 2005 the FDA released a statement warning about the higher potential risks associated with using the patch over oral contraceptives and ordered Ortho McNeil to change the label on the package to reflect this danger, but for many women this was too little too late.

Finding the Right Ortho Evra Birth Control Patch Lawyer

Millions of women continue to use the patch without fully comprehending the dangers to which they are exposed. If you are one of these women or know someone who has suffered from the negative effects of Ortho Evra, you may be entitled to compensation based on your painful experience. Contact an experienced Ortho Evra lawyer now to explore your legal options today. We can answer your questions of "Do I have an Ortho Evra lawsuit?"

Ortho Evra patch patch contains 60% more of the hormone estrogen:

Unfortunately problems began to arise as more and more women began using the patch. The patch contains 60% more of the hormone estrogen because more of the chemical is lost through the absorption process. While enough of the hormone to prevent pregnancy is needed to make it into the bloodstream, too much of can pose serious health risks. The first of such concerns arose in 2004 when an 18-year old woman died due to a blood clot in her lungs allegedly caused by Ortho Evra.

The Ortho Evra transdermal birth control patch was first introduced in 2002 by Ortho McNeil Pharmaceutical Inc. as an alternative to the birth control pill. The patch, as it came to be called, was purported to be as effective at preventing unwanted pregnancy as traditional oral contraceptives, but offered the added convenience of a once a week application rather than a daily pill.

This combination of convenience and effectiveness made Ortho Evra one of the most prescribed types of birth control in the nation, and over four million women have used the patch as their sole means of preventing pregnancy. In fact, Ortho Evra is the only birth control patch approved by the Food and Drug Administration.

An alternative to the birth control pill.

The Ortho Evra patch was considered revolutionary when it debuted in 2002.  Rather than an easily forgettable daily pill, women who wanted to prevent unwanted pregnancy simply attached the patch to the skin on their abdomen, hips, thighs, or back.  The patch is replaced every week of the month except for the fourth, which allows a normal menstrual period. 

Transdermal Hormonal Contraceptives:

The active hormones in the patch are norelgestromin and ethinyl estradiol, which help women regulate their fertility.  Advocates of the patch claim that it is just as safe as birth control pills, but more convenient and effective.

Ortho Evra Injury List:

The known Ortho Evra injury list included these injuries:

• Pulmonary Embolism
• Deep Vein Thrombosis
• Ischemic Strokes
• Myocardial Infarction
• Other blood clots

Some Ortho Evra Side Effects may Include:

The other known side effects of Ortho Evra may include the following: The percentage of women that experience side effects is as high as 2.4%

• Headaches
• Breast symptoms*
• Nausea
• Upper respiratory infection
• Menstrual cramps
• Abdominal pain
• Application site reaction

*Breast symptoms include pain, tenderness, and engorgement.

FDA Study on health risks caused by Ortho Evra.

After this tragic and senseless death, people began to investigate allegations other health risks caused by Ortho Evra. The Associated Press published a 2004 study conducted by the FDA that revealed that Ortho Evra caused a 300% increase of blood clot-related incidents. These blood clots can cause strokes, heart attacks, and pulmonary embolisms which are possibly fatal. The FDA states that only between 1% and 10% off all problems are actually reported, so it is possible that these conditions are actually more prevalent than initially believed.

It's important to take action right away, as restrictive statutes of limitations can prevent you from collecting the restitution you deserve. When consumer safety is jeopardized, drugmakers need to be held accountable.

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