Ortho Evra PatchSide Effects Lawyer

Ortho Evra Introduction

Ortho Evra, also known as birth control patch is a hormonal contraceptive. It uses ca skin patch to transfer estrogen and progestin into the blood stream. Although there is similarity between the hormones present in Ortho Evra and oral contraceptives, side effects are common and severe in than in birth control pill. Women using Ortho Evra are at a higher risk of developing stroke, lethal blood clotting, heart attack and pulmonary embolism. Additional side effects associated with Ortho Evra includes breast enlargement or tenderness, bloating, headache, changes in menstrual cycle and nausea.

Ortho Evra is the first transdermal patch approved by FDA for birth control. Ortho-McNeil Pharmaceutical, Inc. manufactures Ortho Evra. Ortho Evra is beige and thin patch continually releasing hormones ethinyl estradiol and norelgestromin (estrogen and progestin) from the skin directly into the blood stream to avoid pregnancy. The U.S. Food and Drug Administration approved Ortho Evra for the market use in November 2001. It was given as a prescription drug in April 2002.

Recently Ortho Evra has been associated to the deaths among many women in the United States alone.  In March 2004, a 25 year old women and a mother of two Sasha Webber died due to heart attack after using Ortho Evra for six weeks. In April 2004, Zakiya Kennedy, a 18 year old student at Manhattan died at a New York sub way station due to  blood clot  in the lung. According to the medical examiner, Zakiya died due to the side effect of the birth control patch. In November 2004, Kathleen Thoren, 25, died due to blood clot after using Ortho Evra for few weeks.

Recently, Associated Press published the report indicating the severe side effects related to the use of birth control patch. This report states that 23 women using Ortho Evra died due to its side effects.

Ortho Evra and New Warnings

On November 10, 2005, FDA declared that the Ortho Evra birth control patch releases 60 percent more estrogen as compared to birth control pills. Healthcare professionals are aware of the fact that elevated levels of estrogen are responsible for blood clots leading to serious medical problems like pulmonary embolism, heart attack, deep vein thrombosis, stroke and death in healthy and young women. As the warning label of Ortho Evra claims that it is as safe as a birth control pill, FDA asked Johnson and Johnson to increase the warning on Ortho Evra labels highlighting the risks associated with the elevated levels of estrogen releasing from Ortho Evra. Therefore, Johnson and Johnson issued new warning in November 2005.

As the ingredients of the oral combination hormonal birth control and Ortho Evra are same, doctors and patients felt comfortable and confident with this new patch. Moreover, due to the similarities many believed that the patch will not cause any severe side effects.  Although manufacturers of hormonal birth control products and Ortho Evra birth control patch used same ingredients, a clinical trial conducted by FDA proved that women using the patch are at an increased risk of developing blood clot injuries as compared to the women using an oral contraceptive pills. Oral medication is metabolized by the digestive system of the body whereas hormones estrogen and progestin are released directly through the transdermal patch into the blood stream.

According to the Dr. Pamela Berens, at the University of Texas Medical School at Houston, “there may be something about the way the drug is metabolized that could increase the risk for clots.”

If you believe that you are suffering from the side effects of Ortho Evra like pulmonary embolism, heart attack, deep vein thrombosis and stroke , you can file a lawsuit against the company.

Use of Ortho Evra Takes Away dozen women’s life

For the past few years, safety issues related to the use of Ortho Evra have been in question. According to the Associated Press, 23 women taking Ortho Evra died. According to the doctors, of these 23 cases of death, 17 died due to blood clotting .In 2004, approximately, a dozen women using the skin patch, either in their teens or early twenties died due to blood clotting. Another dozen women suffered from blood clots and strokes.

Due to the severe side effects related to the use of Ortho Evra, FDA asked the manufacturers to make the changes in the warning label to imitate the new found information. Therefore, a new warning label was created in November 2005.This new warning clearly indicates that the women using Ortho Evra are subjected to about 60 percent of the total estrogen in their blood, to that of a birth control pill containing 35 mg of estrogen. The estrogen level in the patch remains same for a week until the birth control patch is detached.

Warning label of Ortho Evra claims that it is as safe as a pill. Due to this in November 2005, FDA asked Johnson and Johnson to increase the warning highlighting the risk of injury caused due to elevated levels of estrogen  that are released from the Ortho Evra patch.

Women smokers should not use Ortho Evra. Cigarette smoking raises the risk of severe side effects on the blood vessels and heart due to the use of hormonal birth control methods. These risk further increases in the women above 35 years of age and heavy smokers.

Women having the history of following diseases should not use Ortho Evra:

• Yellowing of the skin or whites of the eye during the use of hormonal contraceptives or during pregnancy
• Stroke or heart attack
• Clotting of the blood in the lungs, legs or eyes
• Cancer of the cervix, uterus or vagina or breast cancer
• High blood pressure
• Clotting of the blood in the veins of the legs
• Diabetic and suffering from the complications of nerves, kidneys, blood vessels or eyes
• Current pregnancy
• Unexplained vaginal bleeding
• Chest pain
• Allergic to Ortho Evra or to its ingredients
• Liver tumor

Ortho-McNeil Pharmaceuticals Inc, manufacturer of Ortho Evra and FDA continually to monitor the side effects associated with the use of Ortho Evra.