Ortho Evra Side Effects

Lawyers Provide the Latest News on Ortho Evra Settlement and Litigation

FDA Launches Ortho Evra Patch Probe

Clinical trials conducted prior to FDA approval of Ortho Evra indicated a higher incidence of blood clots and strokes in women taking the patch.

The medical officer with the FDA reviewing the clinical trials expressed concern over two cases of blood clots in patients participating in the study. In fact, that officer recommended that the product labeling include a warning that reflected the "possible increased risk of venous thromboembolism (blood clots)" associated with Ortho Evra.

Women Using Ortho Evra at Greater Risk for Blood Clots, Strokes

July 16, 2005—The Associated Press reported that women using the Ortho Evra birth control patch were at a significantly greater risk of suffering a blood clot compared to women taking birth control pills.

The AP utilized the Freedom of Information Act to force the FDA to turn over reports of adverse drug reactions for Ortho Evra. The data demonstrated that women using the Ortho Evra patch were three times more likely to suffer a blood clot than those taking pills. The results are particularly alarming because these serious health problems are occurring in young, healthy women.

The FDA reports show that at least 17 women using Ortho Evra have died of blood clots since the patch was approved in November 2001. The actual number of women suffering fatal blood clots while using Ortho Evra patches may be significantly higher, as the FDA estimates it is notified on only a small percentage of adverse drug reactions that occur.

Ortho Evra was approved for use by the FDA in November 2001. The patch is available by prescription only and works by releasing hormones through the skin into the bloodstream to prevent pregnancy.

Warning Symptoms and Side Effects of Ortho Evra

If you are using Ortho Evra and experience any of the following symptoms, you should contact your physician immediately:

• 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)

Ortho Evra Product Label Warning

The professional product label warns that Ortho Evra should not be used in the following circumstances:

• A history of heart attack or stroke
• Blood clots in the legs (thrombophlebitis), lungs (thrombophlebitis), lungs (pulmonary embolism), or eyes
• A history of blood clots in the deep veins of your legs
• Chest pain (angina pectoris)
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
• Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
• Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives such as Ortho Evra, Norplant (levonorgestrel), or the birth control pill
• Liver tumor (benign or cancerous)
• Known or suspected pregnancy
• Severe high blood pressure
• Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
• Headaches with neurological symptoms
• Use of oral contraceptives (birth control pills)
• Disease of heart valves with complications
• Need for a prolonged period of bed rest following major surgery
• An allergic reaction to any of the components of Ortho Evra

What You Should Do

Your Health

Your Legal Rights

If you have suffered a stroke or blood clot while using the Ortho Evra birth control patch, you may be entitled to compensation. You should act immediately to contact a lawyer experienced in matters involving dangerous pharmaceuticals.

Our Lawyers Can Help

O'Steen & Harrison, PLC presently is handling legal claims on behalf of those injured by Ortho Evra. We invite you to contact us for a free, confidential consultation about your legal rights.

We represent patients throughout the United States. We can help you, too, wherever you live.

For free answers to your questions about the Ortho Evra lawsuit, please call us toll-free at 1-800-883-8888 or complete this online contact form.

O'Steen & Harrison, PLC

300 W. Clarendon Ave., Suite 400
Phoenix, Arizona 85013-3424

800.883.8888
info@vanosteen.com

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Ortho Evra News

Group Urges FDA to Take Ortho Evra Off Market
The New York Times | May 9, 2008

J&J Altered Birth Control Patch Data to Hide Risks
Bloomberg | November 29, 2007

Johnson & Johnson Exec Claims He Was Fired for Raising Safety Concerns
Law.com | December 20, 2006

Johnson & Johnson Issues Ortho Evra Patch Warning
NBC5i.com | November 29, 2006

More Ortho Evra News Articles