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Ortho-Evra Can Cause Serious Effects

Millions of women use various forms of birth control to prevent against unwanted pregnancy and/or to relieve the effects of heavy and painful menstrual cycles and to regulate their menstrual cycles. One of the most common forms of birth control, and one many women are familiar with, is the birth control pill, comprised of a combination of estrogen and progestin generally taken orally once daily. However, there are many other forms of birth control on the market, some of which are specifically designed to combat problems associated with the daily birth control pill, specifically, forgetfulness. One such medication is Ortho-Evra, the birth control patch.

Ortho-Evra is considered more convenient than the pill because it is a patch applied to the skin once a week, three weeks a month, eliminating the need to remember to take a pill orally every day. Since Ortho-Evra is a patch that is changed once a week, it decreases the chances associated with typical birth control pills that a woman might miss one or more daily doses. For women who have a problem remembering to take the pill, the patch at first appeared to be a viable solution. Problems associated with forgetting to take daily birth control pills include but are not limited to spotting, cramps, nausea (when patients have to "double up" the next day), and in the most serious of cases, unwanted and/or unplanned pregnancy. Alternatives to the daily birth control pill were needed.

Manufactured by Ortho-McNeil Pharmaceutical Inc. Ortho-Evra is the first transdermal (skin) patch approved for birth control. Ortho-Evra is a thin, beige patch that delivers continuous levels of the hormones norelgestromin and ethinyl estradiol (progrestin and estrogen, respectively) through the skin and into the bloodstream to prevent pregnancy. Unlike oral medication, which is metabolized by the body's digestive system, the progestin and estrogen in the patch are delivered through the transdermal patch and released directly into the bloodstream.

According to the Federal Drug Agency (FDA), some common side effects with combination hormonal contraceptives like Ortho-Evra are:

  • Breast tenderness and enlargement
  • Headache
  • Nausea
  • Menstrual changes
  • Abdominal cramps and bloating

    • Ortho-Evra contains the same ingredients as oral combination hormonal birth control, so both patients and people in the medical community initially felt very comfortable with the patch, and confident it would work in similar ways. Additionally, the similarity has led many to believe that the patch would not be associated with any additional negative side effects. Familiarity with the ingredients wrongly gave the community a sense of trust in this new form of birth control.

    After the Food and Drug Administration approved Ortho-Evra for use in November, 2001 and prescriptions started being written in April 2002, reports surfaced that some very severe and potentially fatal side effects may be associated with the use of the patch.

    Although the manufacturer's Ortho-Evra birth control patch contains the same combination of ingredients as oral combination hormonal birth control products, clinical trial data obtained from the FDA by the Associated Press (AP) suggests that women using the patch have a significantly increased risk of potentially fatal blood clot injuries over those using an oral contraceptive. These injuries include but are not limited to:

    • Pulmonary embolism
    • Stroke
    • Heart attack

    The serious side effects of the Ortho-Evra patch continue to be monitored.

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