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Ortho Evra is the first and only hormone contraceptive available in a transdermal patch. Ortho Evra, often called “birth control in a band-aid,” was fast-tracked through the FDA and received approval in November 2001. Once this birth control patch hit the market in April 2002, its maker, Ortho McNeil (a subsidiary of Johnson & Johnson) aggressively promoted this drug through celebrity endorsements, catchy campaigns, direct-to-consumer coupons, and free samples.
Fast-forward to 2006. Significant concerns have been raised about the safety of the Ortho Evra birth control patch after several reports of serious and fatal adverse events including blood clots, heart attack, stroke, and even death. The following will take you through an explanation of the patch and its unique dangers. If you have suffered serious injury due to this potentially dangerous drug, please contact us to learn more about your legal rights. Our qualified and experienced attorneys can evaluate your case to determine if you may be eligible to seek compensation for your losses and suffering.
Ortho Evra is NOT the “Pill in a Band-Aid”
Ortho McNeil has consistently compared the safety and effectiveness of the Ortho Evra patch to oral contraceptives, though the analogy is inappropriate. The pill and the patch differ in their delivery method, absorption into the body, metabolism, and excretion. According to Ortho McNeil, however, most of their safety data for Ortho Evra is based on studies of oral contraceptive safety. Due to these differences, comparing the safety of oral contraceptives and Ortho Evra is like comparing apples and oranges. In addition, we are discovering that the differences between the patch and the pill create unique—and very serious—risks for Ortho Evra users.
Patch vs. Pill: Delivery Method
Oral contraceptives, which contain estrogen and progesterone like Ortho Evra, are intended for oral ingestion once daily. When swallowed, the birth control pill is processed through the digestive system and is broken down by the liver prior to entering the blood stream. The Ortho Evra patch, on the other hand, delivers estrogen and progesterone transdermally, meaning the hormones enter the blood stream directly.
Patch vs. Pill: Absorption in the body
The pill administers “peakatrophic” exposure to the hormones intended to control ovulation and prevent contraception. This means that shortly after ingesting a pill, hormone levels rise and fall abruptly. The blood stream only contains elevated amounts of estrogen for a short time. With the patch, estrogen and progesterone are continuously absorbed into the skin, exposing the users to high amounts of estrogen for an extended period of time. Studies have also found that the levels of hormone absorbed through the patch vary significantly from patient to patient and can even drastically increase upon changing the patch.
So how do these differences pose an increased risk to patch users? The short answer: the patch exposes women to dangerously high amounts of estrogen, a hormone associated with an increased risk of adverse thrombotic events. The long answer:
History of estrogen use in hormonal contraceptives
When hormonal contraception first became available in the United States, high doses of estrogen were used to ensure the effectiveness of the pill in preventing pregnancy. Many oral contraceptives in the 1960s contained 50 micrograms of estrogen or more. Immediately, experts found that high levels of estrogen drastically increased the risk of blood clots, heart attacks and strokes. Eventually, in 1970, the FDA issued a warning about the risks of blood clots with high amounts of estrogen, and recommended that women take the lowest dose possible to avoid such serious risks. Today, most oral contraceptives contain a maximum of 35 micrograms of estrogen. Many contain even lower doses.
According to drug labeling, the Ortho Evra patch is intended to deliver 20 micrograms of estrogen. HOWEVER, recent research indicates that the patch can deliver much greater doses of estrogen. Due to the patch’s delivery method and absorption of estrogen in the body, the patch can expose women to at least 56 micrograms of estrogen, posing the serious risk of adverse thrombotic events.
In November 2005, Ortho McNeil, under the direction of the FDA, announced that the Ortho Evra patch exposes women to 60 percent more estrogen than an oral contraceptive pill containing 35 micrograms of estrogen. Suddenly, many argue, the patch is no longer looking like the pill in terms of safety and efficacy.
While this statement indicates that the patch can deliver dangerously high amounts of estrogen—amounts the FDA previously deemed unsafe—the Ortho Evra patch remains on the market.
Pre-marketing Ortho Evra warnings
Like most drugs, before the FDA could approve Ortho Evra, the product’s safety and efficacy had to be tested through pre-marketing clinical trials. During these trials, two women using the Ortho Evra patch developed blood clots that traveled to their lungs (called pulmonary embolism). Ortho McNeil did not wish to “count” one of these cases as possibly related to use of Ortho Evra because the patient had undergone surgery. Officials with the FDA however, disagreed strongly with the company’s assessment of these possible risks, stating that the incidence rates quoted in their findings may be misleading.
According to the FDA official, “the label should clearly reflect this reviewer’s safety concern about a potential increased risk” of blood clot problems. The reviewer recommended that reports of blood clots should be closely monitored once the patch was approved. No such stipulations were added to the approval of Ortho Evra and no such monitoring for blood clots took place.
The AP report
Out of concern about the risks posed by Ortho Evra, the Associated Press gained access (under the Freedom of Information Act) to the FDA’s database on reported Ortho Evra side effects. The FDA’s database contained 16,000 reports of adverse side effects experienced by women using Ortho Evra in a THREE-year period. For comparison, only 1,200 adverse reports were filed by Ortho Tri-Cyclen users in a SIX-year period. During a one-year period, 44 serious injuries or deaths were linked to Ortho Evra and 17 Ortho Tri-Cyclen users reported serious injury or death. During this time, the pill had SIX TIMES the number of users than the Ortho Evra patch.
Due to these findings, the AP reported that Ortho Evra users were THREE times more likely to develop blood clots and other adverse thrombotic events, compared to oral contraceptive users. The AP also published information about 23 women who died in 2004 while using the Ortho Evra birth control patch
Ortho Evra death reports According to the AP report, 23 deaths had been linked to use of the Ortho Evra patch, 17 of which were caused by blood clots. Many of the women who died while taking Ortho Evra were otherwise young and healthy without any risk factors for thrombotic complications. One 18-year old student collapsed and died of pulmonary embolism while using the patch. A 25-year old mother died of a heart attack after using the patch for six weeks. Another 25-year old died from a blood clot after only two weeks of using the patch. Women — as young as 14 — have reportedly suffered fatal Ortho Evra side effects. While these deaths have not been definitively linked to Ortho Evra, its maker has admitted that the Ortho Evra patch increases a woman’s exposure to estrogen, and thus her risk of adverse thrombotic events.
Ortho Evra Side Effects Many of the women who died while using Ortho Evra reported severe headaches, vision impairment, nausea, and/or vomiting before suffering serious complications that resulted in death.
The patch is not appropriate for women who smoke, have a history of cardiovascular problems, are taking certain medications, have breast cancer, or have recently undergone surgery. Even without these risk factors, evidence shows that users are at an increased risk of the following serious Ortho Evra side effects:
As of the date of this report (February 2006), Ortho McNeil has sponsored two studies to further evaluate the risks of Ortho Evra. In one of these studies, the risk of blood clots appears to be twice as great in women using the patch, compared to those using oral contraceptives. Neither the FDA or Ortho McNeil have indicated that Ortho Evra may be pulled from the market due to unacceptably high side effect risks. Some argue, it might be headed that way.
Have you or a loved one suffered Ortho Evra side effects?
If you or a loved one have suffered serious injuries that may have been caused by Ortho Evra, we would like the opportunity to help you. Our qualified attorneys are experienced at handling cases of similar nature and are prepared to act in your best interest to help you obtain compensation for your losses and suffering. We offer a FREE, no-obligation consultation so that you can learn more about your legal rights and options. Please contact us today to learn more about Ortho Evra.