Ortho Evra Lawsuit & News Blog

Warning Added to Ortho Evra Birth Control Patch

Fri, 27 Oct 2006 13:47:18 -0400

The FDA announced a revision to the label for the birth control skin patch Ortho Evra. This change includes a new bolded warning about higher exposure to estrogen for women using the weekly patch compared with taking a daily birth control pill containing 35 micrograms of estrogen, a commonly prescribed dose. Higher levels of estrogen may put some women at increased risk for getting blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. (Medscape)

Prescribing Revisions for Ortho Evra

Sun, 22 Oct 2006 13:46:31 -0400

Ortho-McNeil and FDA notified healthcare professionals and patients about revisions to the prescribing information to inform them of the results of two separate epidemiology studies that evaluated the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different oral contraceptive. Although the results of two studies differ, the results of the second study support FDA's concerns regarding the potential for using Ortho Evra to increase the risk of blood clots in some women. (Drug Guide)

Next Generation Birth Control Patch Now in Development

Sun, 15 Oct 2006 08:31:37 -0400

The next generation of contraceptive patches, one that is designed to deliver low doses of birth control hormones over a seven-day period is now being developed

An important benefit of the contraceptive patch is that it delivers the estrogen and progesterone hormones directly into the bloodstream, slowing the rate at which hormones are delivered, without the peak doses to the liver that the pill entails. The contraceptive patch, which is worn for seven days, is designed especially for women who have a hard time remembering to take a daily pill. Transdermal patches can have different designs but are meant to deliver drugs across the skin using passive diffusion.
(Medical News Today)

Ortho Evra Lawsuits Being Filed

Sat, 14 Oct 2006 08:32:32 -0400

Lawsuits are being filed on behalf of young women who were using the Ortho Evra birth control patch and suffered strokes, heart attacks, deaths, blood clots, pulmonary embolism, and other serious injuries. These types of injuries are very uncommon in young women. When a woman in her 20s or 30s has a stroke, you have to wonder what is going on with the medications that she is taking. Studies have shown that the Ortho Evra patch causes many more injuries than the ordinary pill.

Ortho Evra birth control patch lawsuits have been filed nationwide alleging the manufacturer of the patch alleging that it was aware of these serious risks and yet continued to aggressively market it to young women. Many of these lawsuits have been quickly settled by the manufacturer. The Ortho Evra settlements are confidential and the amounts have not been publicized.

In 2001, when Ortho Evra was first released on the market, Ortho McNeil, a division of Johnson and Johnson claimed that the risks associated with the birth control patch were about the same as the risks of using the birth control pill. Lawsuits filed in U.S. District Court in Ohio allege that the company knew at the time of the increased risks to women, but concealed these risks for financial gain while aggressively marketing to young women. Now it seems the company wants to settle cases.
(Yahoo)

Ortho Evra Patch Labeling Updates FAQ

Wed, 4 Oct 2006 10:52:33 -0400

September 20, 2006--Information provided by Johnson & Johnson on Feb. 16, 2006 was based on an interim report from one of the two epidemiological studies. The label is now being updated with the available results from the two studies. These two studies were conducted to evaluate the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different, commonly prescribed, oral contraceptive. Concern about this risk was originally based on reports to the FDA about serious blood clots suggested that Ortho Evra may have a greater risk for venous thromboembolism (VTE) for at least some women, compared to oral contraceptives.

Even though the results of the two studies are conflicting, the results of the second epidemiology study support the FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women. The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their healthcare provider about using Ortho Evra versus other contraceptive options. (FDA)

Texas Woman Sues Johnson & Johnson's Ortho Evra Patch

Mon, 4 Sep 2006 10:53:34 -0400

A Texas woman who suffered a miscarriage and developed blood clots after using the Ortho Evra birth control patch has filed a federal lawsuit against Johnson & Johnson. The complaint says the package insert that came with Ortho Evra was misleading and in direct conflict with Johnson & Johnson's own data. According to the prosecuting law offices, the insert suggests the risk of blood clots among Ortho Evra users is equivalent to that of women using other oral contraceptives. (Read Here)

FDA to review Patches

Sat, 25 Mar 2006 07:11:33 -0400

The Food and Drug Administration announced last week it will launch an
"exhaustive review" concerning the safety of medical patches, including
Ortho Evra birth control patch and fentanyl pain patch both manufactured
by Johnson & Johnson.

As drug companies continue to produce more and more patches the FDA just
approved the first antidepressant patch last week - researchers worry
medical patches may become unsafe when exposed to heat from exercise,
hot tubs, or fevers, which could lead to fatal results.
Full Story:

Clot Risk for Birth-Control Patch Is Found to Be Double That of Pill

Sat, 25 Feb 2006 11:48:14 -0400

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, the Food and Drug Administration said Friday.

Risks of blood clots in legs and lungs are twice as high for women using the birth-control patch instead of the pill, says a study reported by the drug maker and the Food and Drug Administration .

The investigation by The Associated Press found that patch users die and suffer blood clots at a rate three times higher than women taking the pill. About a dozen women died in 2004 from blood clots believed linked to use of the patch, the AP reported. Dozens more suffered strokes and other clot-linked problems. Preliminary findings from the second study, by i3 Drug Safety, found a two-fold increase in the risk of blood clots in the legs and lungs for women using the patch. Complete data from the second study have not been released publicly.

Manufacturer Ortho-McNeil Pharmaceutical Inc. said it is cooperating with the FDA in the scientific investigation. The results of the study, and another that found no increased risk, were made public Thursday by the patch's manufacturer.

Because estrogen can promote the formation of blood clots, women taking any hormonal contraceptive run the risk of such side effects. But with the patch, the total level of estrogen exposure is 60 percent higher than with a typical birth control pill, according to the FDA.

According to Dr. Elizabeth Ricanti/Cleveland Clinic, "If A Blood Clot Gets Lodged In An Artery Or Vein That Compromises Blood Flow Than The Patient Can Be At Risk For A Stroke."

Since the patch went on sale in 2002, more than 4 million women have used it.

Birth-Control Patch Users Face Clot Risk

Mon, 20 Feb 2006 09:44:45 -0400

WASHINGTON - Risks of blood clots in legs and lungs are twice as high for women using the birth-control patch instead of the pill, says a study reported by the drug maker and the
Food and Drug Administration.

"For some people the patch may be better because some people don't reliably take the pill, or don't want to take the pill or forget the pill," Daniel Shames, MD said. "So the patch does offer them some alternative for contraception...These are fairly unusual events," said Shames. He noted that in preapproval testing of the patch on about 3,000 women there were two reports of blood clots, but one involved a woman who had had surgery.

Health officials warn that women who smoke should not use the patch, since smoking increases the risk of stroke and heart attack.

Lawsuit - Ortho Evra Patch. Birth control patch lawsuits.

Tue, 14 Feb 2006 08:57:10 -0400

A request has been made for national class-action certification for medical monitoring of patients who may have further complications associated with the Ortho patch. J&J is the maker of the patch as well as Johnson & Johnson also makes oral contraceptives such as Ortho Tri-Cyclen birth control pills. (Ortho tricyclen patch lawsuits involve the patch, not the pill). The patch lawsuitalleges that the company failed to disclose those serious and possibly deadly health risks and printed only that the patch was siilar to other forms of birth control.
The patches contain high doses of estrogen and some experts believe the birth control patch (patches) to be dangers because the birth control patch increases exposure to estrogen is too high. These allegations will be tested in every one of the birth control patches suit.