Ortho Evra Contraceptive Patch Information

posted on:
April 27, 2007

author:
Staff

Ortho Evra is the first transdermal (skin) patch approved for birth control. The weekly prescription patch releases norelgestromin (a progestin hormone), and ethinyl estradiol (an estrogen hormone), through the skin into the blood stream to prevent pregnancy. The U.S. Food and Drug Administration approved Ortho Evra, manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson, in November 2001.

Ortho Evra, an alternative to birth control pills, is a one-and-three-quarter inch square patch consisting of three layers. The hormones are embedded in the adhesive layer and are slowly released when the patch is applied to the skin.

According to the FDA, women who choose to use the product should apply it to the lower abdomen, buttocks or upper body but not to the breasts. Each patch should be worn continuously for one week and should then be replaced with a new patch on the same day of the week for a total of three weeks of patch wear.

The fourth week, which is patch-free, allows a woman to have her menstrual period – similar to the regimen for birth control pills.

Like birth control pills, Ortho Evra is effective for prevention of pregnancy when used as directed. The risks of using this product are similar to the risks of using birth control pills including an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.

In April 2004, an 18-year-old New York fashion student died while using the Ortho Evra patch. According to officials for the FDA and Ortho McNeil, the death is the first linked to the contraceptive patch. Information from the Medical Examiner’s Office indicates Zakiya Kennedy’s death was caused by a blood clot.

In November 2005, Ortho McNeil issued a warning to millions of women revealing that the patch exposes them to significant amounts of estrogen and may put them at greater risk of developing blood clots.

Based on an internal company memo, Ortho McNeil refused to fund a study which would have compared the Ortho Evra patch to the company’s Ortho-Cyclen birth control pill. The company was afraid that the results of such a study may not be positive for the patch. However, the company now states that it plans to conduct a study for the patch, similar to studies previously conducted with the Pill. The Ortho Evra website states that prior to marketing the patch, it had been studied on over 3,000 women.

In September 2006, Ortho and FDA notified healthcare professionals and patients about revision 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. The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micro grams of ethinyl estradiol and norgestimate. The second study found an approximate 2-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micro grams of estrogen. Although the results of the two studies differ, the results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.

See your doctor if you have experienced serious health problems after using the Ortho Evra patch. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

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