|
 |
|
Practice Areas | Ortho Evra®
On November 20, 2001, the FDA approved the Ortho Evra contraceptive skin patch which was the first transdermal (skin) contraceptive approved for use in the United States. Despite a disagreement between an FDA reviewer's and the manufacturer's interpretation of safety data obtained in pre-market clinical trials, in approving the Ortho Evra contraceptive skin patch, the FDA stated that "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."
 Now, on November 10, 2005 - almost four years later to the day the Ortho Evra patch was approved - the FDA announced that the labeling for the Ortho Evra birth control patch was changed to include "a new bolded warning about the higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill...Higher levels of estrogen may put some women at increased risk for getting blood clots."
Blood clots can result in a heart attack, stroke or pulmonary embolism requiring immediate and extensive medical care. Estrogen, a component of most oral contraceptives and the Ortho Evra birth control patch, has long been associated with an increased risk of developing blood clots. Unlike oral contraceptives that deliver estrogen through the digestive system, the Ortho Evra birth control patch delivers estrogen through the skin and directly into the blood stream. As a result, the amount of estrogen released into the body appears to be approximately 60% greater with the Ortho Evra birth control patch than it is with oral contraceptives.
On February 16, 2006, the manufacturer of the Ortho Evra® birth control patch disclosed the results of an unpublished epidemiological study supporting the belief that the use of the Ortho Evra® birth control patch poses a greater risk of developing blood clots than that posed by oral contraceptives. The recent study, funded by the manufacturer of the Ortho Evra® birth control patch, concludes that, when compared to oral contraceptives, the use of the Ortho Evra® birth control patch doubles the risk of developing venous thrombosis (blood clots and deep vein thrombosis). This increased risk is believed to be attributable to the transdermal hormonal delivery system that is unique to the Ortho Evra® birth control patch. The transdermal patch delivers estrogen directly into a woman’s blood stream whereas oral contraceptives provide estrogen through the digestive system. Absorption through the blood stream is greater and more rapid than absorption through the digestive system.
On February 17, 2006, the FDA held a news conference to assure the public that the FDA is monitoring the results of this and other studies designed to study the risk of blood clots and other thromboembolic injuries (e.g. pulmonary embolism, heart attack, stroke, sudden death) and the use of the Ortho Evra® birth control patch. However, Daniel Shames, M.D., director of the FDA’s Division of Reproductive and Urologic Drug Products, said "At this time we do not plan on taking any specific regulatory action based on these preliminary results."
If you or a loved one has suffered a heart attack, stroke, sudden cardiac death, or a pulmonary embolism while using the Ortho Evra Patch and have questions about your legal rights, please click HERE to fill out our free case evaluation form.
|
 |
|
