Ortho Evra Information
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Frequently Asked Questions about Ortho Evra™
Q: What is Ortho Evra™?
A: Ortho Evra is a contraceptive patch that women can wear on the lower abdomen, buttocks or upper body. The patch is applied once each week, for three weeks. A patch is not used on the fourth week during a woman's period. The Ortho Evra patch delivers the same drugs, norelgestromin and ethinyl estradiol, that are used in many birth control pills. Like the pill, Ortho Evra does not protect against HIV infection (AIDS) or other sexually transmitted infections.
Q: How is the birth control patch different than the birth control pill?
A: While the birth control pill delivers a higher peak concentration of hormones because it is taken daily, the patch delivers a higher concentration of hormones over the course of a week thus exposing a woman to greater amounts of the drugs. Studies cited by the Food & Drug Administration indicate that women using the patch may be exposed to 60 percent more estrogen than women using the pill. Additionally, drugs from the patch enter the blood stream directly through the skin, rather than metabolizing through the digestive system like oral contraceptives.
The Food & Drug Administration approved a new warning label for Ortho Evra, stating that the patch exposes women to about 60 percent more estrogen than the birth control pill. If you have been harmed by the side effects of Ortho Evra, contact an experienced attorney to learn about your rights.
The Pill or the Patch: A Dangerous Dilemma
The Ortho Evra transdermal patch has been marketed as an easy alternative to the pill for women seeking convenient, safe and reliable birth control. But Ortho Evra has been implicated in cases of heart attack, stroke, pulmonary embolism and deep vein thrombosis (DVT).
If you suffered any of these serious side effects or a loved one died suddenly while on the Ortho Evra birth control patch, we invite you to call the Dallas office of Miller, Curtis & Weisbrod toll-free at 888.987.0005 to discuss your case with an experienced attorney.
Ortho Evra - An Overview
Ortho Evra Developed by Ortho-McNeil for Release in United States
Ortho-McNeil™ released Ortho Evra™ in the United States after the Food & Drug Administration (FDA) approved the drug for release on the market in late 2001. Ortho Evra is a birth control patch applied once a week to the upper arm or torso, abdomen or buttocks. During the fourth week, no patch is applied to allow for menstruation.
Ortho Evra has been linked to serious blood clotting causing injury or death. Families who have lost a loved one should contact an experienced attorney at Miller, Curtis & Weisbrod, L.L.P. in Dallas, Texas to discuss their options. Women who are currently using the Ortho Evra birth control patch and who may be at risk should first seek medical advice, and then contact an attorney at Miller, Curtis & Weisbrod, L.L.P. for legal advice.
The Health Risks Associated with Ortho Evra
Ortho Evra is a birth control patch that delivers the hormones estrogen and progestin through the skin in order to prevent ovulation. These hormones are also used in other types of contraception, including the birth control pill, so many of the risks associated with the drugs are well known. Estrogen promotes blood coagulation so blood clots and blockages are serious known risks. Since patch users are exposed to more than twice as much estrogen as pill users, researchers are concerned that they are at greater risk for all estrogen-related problems. If you or a loved one has been injured after using Ortho Evra, contact an attorney for advice on your personal injuries.
FDA Action on the Ortho Evra Patch
Ortho-McNeil™, a subsidiary of Johnson & Johnson™, developed Ortho Evra™ and applied for Food & Drug Administration approval in 2000. Ortho-McNeil conducted clinical trials on the patch and determined that its risks were similar to oral contraceptives. In fact, early studies conflicted on the risks to users. One study concluded that risk levels were the same for patch users and oral contraceptive users alike. Another study concluded, however, that users of a patch had double the risk of a serious blood clotting event. Whether Ortho-McNeil put much stock in the study results is unclear. Like other transdermal devices, such as the nicotine patch, Ortho Evra was touted by its maker as an easy-to-use alternative to daily pills.
The FDA first took action on Ortho Evra when it approved the patch for release to consumers in late 2001. The FDA reviewed the drug several times in 2002, but did not begin to order label changes to the product until 2005. These label changes did not occur soon enough for some women. If you or a family member was injured using Ortho Evra, an attorney can discuss your options with you.
Alternatives to Ortho Evra
Perhaps you have suffered mild skin irritation while using the patch. Or perhaps the side effects you feel are more serious, such as headaches or pain in your leg or arm. Any woman using Ortho Evra™ should work closely with her doctor and monitor her health. Women who used the patch without knowing their potential exposure to estrogen, and have suffered an injury as a result, should contact an attorney to take action to seek compensation for their injuries.
The Ortho Evra Litigation
While the Ortho Evra™ patch was initially marketed as an effective alternative that was as safe as the pill, after several years on the market, it became clear that women using the patch suffered greater risks of serious injury or death than women using the pill. In 2005, the Associated Press reported that in 2004, several women died while using the patch, and many more had been serious injured by blood clots associated with the patch.
While many deaths and injuries to Ortho Evra users were discovered in 2004, some women are just discovering their injuries. If your physician has diagnosed you with an injury related to your use of the patch, you need dedicated legal counsel to pursue your claims for damages.
Ortho Evra Resource Links
FDA Updates Labeling for Ortho Evra Contraceptive Patch
You can read the Food & Drug Administration (FDA) press release in 2008 regarding new labeling requirements for the Ortho Evra contraceptive patch.
FDA Information on New Label for Ortho Evra
Read FDA questions and answers discussing new language for Ortho Evra label that includes results of a study on the risks of serious blood clots for Ortho Evra users.
Ortho Evra Drug Information
Ortho-McNeil's Web site provides prescribing information, side effects and adverse reactions associated with Ortho Evra for consumers and medical professionals.
WebMD: Stronger Warning for Birth Control Patch
Read a report from WebMD Health News, an online medical resource, on FDA's update of the Ortho Evra label.
Public Citizen Petitions for Removal of Ortho Evra from the Market
Read the press release accompanying Public Citizen's petition to the FDA to remove Ortho Evra from the market because of its risks to female users.
