Ortho Evra

FDA Warns Ortho Evra Contraceptive Patch Users
Ortho Evra Contraceptive Patch News Alerts and Lawyer Updates

The Food and Drug Administration (FDA) announced on November 11, 2005 that the Ortho Evra contraceptive patch exposes millions of women who use the patch to levels of estrogen far higher than most daily birth control pills, putting them at higher risk for blood clots than previously disclosed. The FDA also approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients about the increased risk.

The warning from Johnson and Johnson subsidiary Ortho McNeil, makers of Ortho Evra patch, states that the patch exposes women to 60 percent more estrogen than daily birth control pills, which contain 35 micrograms. Ortho Evra is the first and only skin patch approved for birth control, and more than 4 million women have used the patch since it came on the market three years ago. The patch releases ethinyl estradiol, an estrogen hormone, and norelgestromin, a progestin hormone, through the skin into the bloodstream. It only needs to be changed once a week.

The Associated Press in July reported that, according to FDA records it obtained through a Freedom of Information Act, women using Ortho Evra in 2004 were three times as likely as women using birth control pills to die or develop nonfatal blood clots. The Associated Press learned that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 in 2004.

Since the FDA estimates that it receives reports of only between 1 percent and 10 percent of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.

The Ortho-Evra patch, which is available by prescription only, has not yet been pulled off the market. The drug maker says it is launching its own study with input from the FDA to assess the dangers of using the patch. Women who may be using Ortho Evra should contact their physician if any of the following warning signals develop:

• Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)

• Pain in the calf (indicating a possible clot in the leg)

• Crushing chest pain or tightness in the chest (indicating a possible heart attack)

• Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)

• Sudden partial or complete loss of vision (indicating a possible clot in the eye)

• Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health care professional to show you how to examine your breasts)

• Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)

• Severe problems with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)

• Jaundice or a yellowing of the skin or eyeballs accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems)

We bring this important information to your attention to better educate you about the risks and dangers of prescription and pharmaceutical drugs.

ORTHO EVRA CONTRACEPTIVE PATCH NEWS & LAWYER UPDATES

Johnson & Johnson, the makers of Ortho Evra, possibly knew of the birth control patch’s dangerous side effects several years ago, according to an NBC Today Show investigative report that came out September 22, 2010.

The NBC report states that patient reports from 2002 to 2004 showed that women using the patch had a 12 percent increased risk for stroke and an 18 percent higher risk for blood clots compared to women who used conventional oral contraceptives.

This information compelled a former Johnson & Johnson vice president to resign, saying in a resignation letter obtained by NBC News that the “estrogenic exposure [of the patch] was unusually high, as was the rate of fatalities.”

Another former Johnson & Johnson executive is suing the company for wrongful termination, alleging he was fired after blowing the whistle on the dangers associated with Ortho Evra.

When it first came out in 2002, the Ortho Eva patch was hailed as being an alternative to oral contraceptive pills. However, in 2005, the U.S. Food and Drug Administration (FDA) warned that the patch’s delivery of a continuous, high level of estrogen greatly increased users’ risk of blood clots (venuous thromboembolisms), strokes and heart attacks.

As a result, Johnson & Johnson changed the product’s label to provide a warning that its own studies had shown a doubling of the risk of serious blood clots from use of the patch.

Despite alleged injuries and deaths claimed to be related to the Ortho Evra patch, it remains on the market. Several lawsuits have been filed against Johnson & Johnson and petitions have been filed with the FDA, asking to have the product pulled.

FDA Warns Ortho Evra Contraceptive Patch Users
CBS News - November 11, 2005
... The Food and Drug Administration has issued a public warning on Ortho Evra Contraceptive Patch blood clot risks

FDA says patch has blood clot risk
CNN - November 11, 2005
... The Food and Drug Administration on Thursday warned millions of women who use the Ortho Evra contraceptive patch that they are being exposed to about 60 percent more estrogen than with a typical birth control pill, which could put them at higher risk for blood clots.

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