Ortho Evra is a contraceptive skin patch used to prevent pregnancy. It was the first skin patch approved for birth control. Ortho Evra is manufactured by Ortho Women's Health & UrologyTM, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. based in Raritan, New Jersey. The patch is applied weekly and works by delivering continuous levels of hormones (progestin and estrogen) into the bloodstream through the skin. Basically, the patch works similarly to the birth control pill in that it prevents ovulation.
Since its FDA approval in 2001, the Ortho Evra birth control patch has been used by more than 4 million women and generated sales in the amount of $1.6 billion. To date, doctors have written over 40 million prescriptions for Ortho Evra. It was not until November, 2005 that the public was warned about the significant side effects of Ortho Evra.
On November 10, 2005, the FDA released a statement indicating that the Ortho Evra contraceptive patch exposes women to higher levels of estrogen than most birth control pills. The FDA required that all packaging for Ortho Evra contain a new bolded warning specifically stating that women who use the patch are exposed to about 60% more total estrogen in their blood that if they were taking a typical birth control pill. When a typical birth control pill is swallowed, it quickly dissolves into the system. However, with the birth control patch, estrogen is steadily released into the body over the course of an entire week.
Studies between 2002 and 2004 have shown that this increased level of estrogen dramatically increases a woman's chances of suffering a blood clot or stroke. In fact, these studies show that Ortho Evra was 12 times more likely to cause stroke and 18 times more likely to cause blood clots than a normal birth control pill.
In addition to blood clots and stroke, Ortho Evra has also been linked to the development of DVT's (deep vein thrombosis), pulmonary embolism and heart attacks. There have also been reports of death associated with the use of Ortho Evra.
In September, 2010, NBC News broke a story surrounding internal Johnson & Johnson documents which showed the elevated risk of stroke and blood clots associated with Ortho Evra use. NBC News reported that the pharmaceutical giant may have known about the deadly side effects of Ortho Evra years ago. NBC News discovered that concern over the patch has led to high-level resignations at Johnson & Johnson. Dr. Sidney Wolfe, who is the Medical Director of the watchdog group Public Citizen, petitioned the FDA two years ago to remove Ortho Evra from the market. The FDA has yet to make a decision in this regard. Watch the full story here.
If you or a loved one has used the Ortho Evra Birth Control Patch and suffered a blood clot, DVT, pulmonary embolism, heart attack or stroke, please contact our office for a free legal consultation.
