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Overview
In 2001, the Ortho Evra patch was embraced by women everywhere. Thousands flocked to their family physicians to obtain subscriptions for the weekly birth control patch. Since the introduction of Ortho Evra, the FDA has received more than 9,000 reports of side effects associated with the patch. This number is exceptionally high when compared to other forms of birth control, which report far fewer cases with unfavorable reactions to the medication.
The Product
Ortho Evra is a contraceptive skin patch. It is the first form of reversible weekly birth control that is as effective as the pill when used correctly. The patch is simple to use. It is worn on the body (anywhere but the breasts) for one week, and then discarded and replaced for three weeks in a row. Then, users have a patch-free week when they have their period. Ortho Evra is small and very thin, undetectable under clothing, giving women a discreet, less-demanding birth control option.
The Ortho Evra patch contains the same combination of female hormones found in the pill-estrogen and progestin. These hormones are delivered through the skin in a steady flow over the seven-day period. They prevent the ovary from releasing an egg and cause changes in the uterine lining which make it more challenging for the sperm to reach the uterus and make it difficult for a fertilized egg to attach.
Side Effects
Since 2002, the Ortho Evra patch has been prescribed to over four million women. Due to its convenience and ease of use, it at first rose rapidly in popularity. The most serious side effect which has appeared since its introduction is an increased risk of developing blood clots.
According to a study released by the Food and Drug Administration in July 2005, women who use the Ortho Evra patch receive exposure to 60% more estrogen than women on the pill, and are three times more likely than birth control pill users to develop serious side effects, such as venous thromboembolism. This is a condition in which blood clots form in the veins and break loose, traveling to the lungs, creating a deadly blockage in the blood vessel.
Other side effects associated with use of the Ortho Evra patch include: strokes, weight gain, blood clots, severe headache, depression, vomiting, nausea, nervousness, dizziness, tiredness, hair loss, vaginal dryness, vaginal itching, decreased sex drive, inability to wear contact lenses, vision problems, pulmonary embolism, deep vein thrombosis and death.
FDA Warnings
Between 2002 and 2005, the FDA linked 23 deaths to the use of the Ortho Evra patch by women between the ages of 17 and 30. Many of these women were healthy, with no history of cardiovascular conditions or blood clots. They died as a result of heart attacks, strokes and other side effects of Ortho Evra.
These findings, coupled with unfavorable study results, put pressure on Ortho-McNeil (the company that makes Ortho Evra) to improve the warning label and informative inserts that are included with every prescription of Ortho Evra. This warning concerning side effects came too late for the women whose deaths were connected to the use of Ortho Evra, however. Since then, many doctors have advised women to stop using the Ortho Evra patch in order to avoid developing serious side effects, but to date there has been no product recall of Ortho Evra.
Lawsuits
As a result of the recent studies revealing the adverse side effects from using Ortho Evra, birth control patch users may be eligible to file a lawsuit. Attorneys specializing in the birth control patch claim that many Ortho Evra users were not adequately advised when the patch was prescribed and were not notified when new information about Ortho Evra's side effects came into light.
At Risk
Women of all ages are at risk for developing harmful side effects from the Ortho Evra patch. This is primarily due to the high level of hormones involved in the product's normal usage. However, women between the ages of 14 and 35 have the greatest chance of developing life threatening blood clots or suffering from strokes or other serious conditions that develop as a side effect of applying the Ortho Evra birth control patch.
