Ortho Evra Patch PDF Print

Serious Side Effects Associated with Ortho Evra Patch

Are you aware of the serious risk associated with Ortho Evra? Your health could be in danger! Read more to find out more about the potentially deadly side effects and whether you qualify for an Ortho Evra lawsuit. Ortho Evra is a prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen.

Have you suffered the following serious side effects as a result of using the Ortho Evra birth control patch?

  • pulmonary embolisms,
  • deep vein thromboses (DVTs),
  • heart attacks
  • ischemic strokes.

FDA Approves Update to Label on Ortho Evra Birth Control Patch; cites risk of developing serious blood clots, also known as VTE. VTE can lead to pulmonary embolism.

Click here for more FDA WARNINGS

Breaking News, January 18, 2008--The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thrombo-embolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.

The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women aged 15-44.

These recent findings support an earlier study that also said women in this group were at higher risk for VTE.

"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

"This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products."

More FDA Warnings Added to Ortho Evra Label Regarding Increased Blood Clot Risk

September, 2006: The U.S. Food and Drug Administration (FDA) announced that it had added updated warnings to the prescribing information for the Ortho Evra birth control patch.  The Ortho Evra patch is manufactured by Ortho Women's Health & Urology, a company owned by Johnson & Johnson.

The FDA's updated warning comes in response to two separate studies sponsored by the pharmaceutical company that were designed to evaluate the risk of developing a serious blood clot when using the Ortho Evra patch as compared to women using a different oral contraceptive.

The results of one study found that women using the Ortho Evra patch faced twice the risk of clots than did women using the pill. The FDA has requested longer follow-up for venous thrombo-embolism, heart attack and stroke.

If you think you have been harmed by Ortho Evra contact a Dangerous Drugs Attorney at Charlip Law Group, LC. For a free, confidential medical case evaluation click here. Let us help you through this difficult time.

At Charlip Law Group, LC our attorneys will represent your matters with the full consideration and respect you deserve. The lawyers at our firm bring many years of training and experience to the practice of law. Our multi-lingual staff will deal with your issues promptly. We are conveniently located in Broward County. Our South Florida location allows us to serve our clients in Miami-Dade, Broward and Palm Beach Counties; throughout Florida and the United States. Contact Charlip Law Group, LC at our Hollywood, Florida offices toll-free at 1-800-773-1955 or 954-921-2131. You can send us a confidential email at This e-mail address is being protected from spambots. You need JavaScript enabled to view it