Drug Injury

Stewart & Stewart Injury Lawyers

Ortho Evra®

Consult with your physician if you have questions concerning this medication.

Ortho Evra® Dangers

Ortho Evra® is the number one prescribed birth control brand in the United States (1) and is known as a "transdermal contraceptive system." Ortho Evra is a birth control patch that is applied to the arms, torso, abdomen, or buttocks once a week and offers “the same efficacy as the Pill with even greater simplicity (1).” It turns out, however, that women using the Ortho Evra patch are at an increased risk for fatal blood clots compared to women taking birth control pills.

The Associated Press (AP) reported that in 2004, when over 800,000 women were using the patch, the risk of dying or suffering a survivable blood clot while using the patch was about three times higher than while using birth control pills (2).

In November 2005, the labeling on the Ortho Evra patch was updated to include a bolded warning that the patch exposes women to higher levels of estrogen than most birth control pills. Elevated levels of estrogen may increase the risk of blood clots (3).

The new warning label states, “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 of estrogen. In general, increased estrogen exposure may increase the risk of side effects (4).” This is partly due to the fact that the absorption rate of a pill traveling through the digestive system is much lower than the patch, which delivers estrogen into the bloodstream 24 hours a day (5).

Update: The U.S. Food and Drug Administration said on September 20, 2006, that it has updated the label on the Ortho Evra birth-control patch, warning that some women who use the product face a higher risk of blood clots (7).

The label revision came after the final results of a study, commissioned by the drug’s maker [...] found that users face twice the risk of clots in the legs and lungs than women taking traditional birth-control pills.

The Ortho Evra birth control patch has been available in the U.S. since April 2002.

Ortho Evra and Fatal Blood Clots

The AP reported that prior to Ortho Evra’s approval, the Food and Drug Administration (FDA) had noted a prevalence of nonfatal clots occurring three times more in patch users vs. pill users; the death rate of patch users was also three times higher (2). A New Jersey Superior Court suit filed by ten women who claimed they experienced blood clotting problems after using the Ortho Evra contraceptive patch notes the FDA collected 9,116 adverse reaction reports from patch users in just 17 months (about 536 a month) vs. 1,237 adverse events in pill users in six years (about 17 a month) (6).

In 2000, doctors reviewing the possible dangers of the patch suggested blood clots could be problematic if the patch was allowed on the market. One FDA reviewer said “the label should clearly reflect this reviewer’s safety concern about a potential increased risk [of blood clots]” and went on to suggest monitoring patch users for clotting problems after the patch went public. When the patch was approved in 2001, there was no required follow-up, despite the FDA reviewer’s recommendations.

Using the Freedom of Information Act (FOIA) the AP was able to view the FDA’s database of 16,000 adverse reactions to the Ortho Evra patch which included skin reactions and death. Seventeen deaths appeared to be clot-related. The women who died were young and at an apparently low risk for blood clots.

What are blood clots and why are they dangerous?

Blood clots are jelly-like semisolid masses of blood tissue that coagulate in the body at the site of a wound in order to stem bleeding from the affected area. Clots can form inside a vessel and break off into the bloodstream, resulting in the blockage of blood flow to areas of the body, often with fatal results.

There are two forms of dangerous and potentially fatal blood clots leading to stroke, as defined by the National Institute of Neurological Disorders and Stroke:

Thrombosis– the formation of a clot within a blood vessel of the brain or neck.

Embolism– the movement of a clot from another part of the body such as the heart to the neck or brain. These traveling blood clots are known as emboli (plural for ‘embolism’) and can kill depending on where they lodge in the body.

Hormonal birth control is known to increase the chance of blood clots in the body because estrogen promotes coagulation. Clots usually form in the legs and become serious problems if they travel to a woman’s heart, lungs, or brain.

What are the warning signs of stroke?

Stroke occurs when the brain doesn’t receive an adequate amount of oxygen to sustain function. The following symptoms should be immediately followed by a call to your doctor or your local emergency services:

• Sudden numbness or weakness of face, arm, or leg, especially on one side of the body
• Sudden confusion, trouble speaking, or difficulty understanding
• Sudden trouble seeing in one or both eyes
• Sudden difficulty walking, dizziness, loss of balance or coordination
• Sudden severe headache with no known cause
  

Additional symptoms may include double vision, drowsiness, nausea, or vomiting. Sometimes symptoms occur only for a moment, but could require medical attention. These short episodes are known as transient ischemic attacks, or TIAs, and may reveal a potentially life-threatening condition.

What should I do if I use the Ortho Evra patch?

Never stop taking any medication without first consulting your physician. Suddenly discontinuing your birth control may be dangerous to your health and result in pregnancy.

If you or someone you care about has suffered serious adverse side effects after using the Ortho Evra patch such as blood clots or cardiovascular complications, specifically a thrombotic or embolic clot requiring hospitalization, contact our law firm immediately for a free and confidential case evaluation.

Sources:

1. About Ortho Evra accessed on 10/11/05.
   
   
2. "AP finds more fatalities from birth control patch than expected" from The Boston Globe accessed on 10/11/05.
   
   
3. "FDA Updates Labeling for Ortho Evra Contraceptive Patch" from the Food and Drug Administration accessed on 11/14/05.
   
   
4. New Important Labeling Information from the Ortho Evra Web site accessed on 11/23/05.
   
   
5. "US Drug Maker Issues Warning About Birth Control Patch" by Martha Mendoza, The Associated Press, accessed on 11/23/05.
   
   
6. “NJ Suit Links Ortho Evra Patch to Blood Clots,” 08/08/05,      Medical Devices Litigation Reporter Volume 12, Issue 12.
   
   
7. "FDA Updates Warning on Contraceptive Patch," 09/20/06, Medicine Online, accessed on 11/01/06.

Consult with your physician if you have questions concerning this medication. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Ortho Evra® is a registered trademark of Ortho-McNeil Pharmaceuticals, Inc. and is used here only to identify the product in question.

This law firm is not affiliated with, sponsored by, or associated with Ortho-McNeil Pharmaceuticals, Inc., the Boston Globe, the Food and Drug Administration, the National Institute of Neurological Disorders and Stroke, Medical Devices Litigation Reporter, or The Associated Press.