Women who use the Ortho Evra Patch are at much greater risk of developing blood clots and stroke compared to other forms of oral contraceptives. Also, many deaths have been linked to the patch. The drug's manufacturer finally admits that women who use the patch are taking up to 60 percent more estrogen than if they were taking the oral birth control pill.
For many sufferers and victims, the manufacturer's acknowledgement has come too late. Four months before the manufacturer Ortho McNeil issued this recent warning, The Associated Press (July 18, 2005) reported a link to blood clots and death in young women taking the patch. FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots, and strokes since August 2002.
Countless others have suffered other serious injuries such as strokes and clot-related problems. Lisa Fought is 38 years old and a registered nurse. She has never had a history of blood clots, neither has any member of her family. Until now. "I developed a blood clot in my leg and one week before it happened, I read how much more estrogen you were exposed to on the patch. If I knew that, I would never have taken it," says Fought.
"I was still having heavy bleeding on the patch and spotting, but my gynecologist said to give it another month," she says. (Her gynecologist prescribed the birth control patch because she has a history of endometriosis and suffers from heavy periods.) "But one morning I got out of bed and had such severe pain in my leg that I dropped back on the bed, tears pouring out of my eyes it hurt so bad... I thought right away it was a blood clot."
The pain developed on Saturday and within one day she developed a red streak behind her knee. Fought went to the hospital and had an ultrasound, which confirmed that she did indeed have a blood clot in her leg. "It was in a smaller vein so there wasn't any immediate danger and I went home to rest," she says. But five days later it got bigger. Her gynecologist told that her hormone therapy days were over.
"This has made other problems a big mess. With hormone therapy, the bleeding would have been minimized and endometriosis would have been controllable," says Fought. "Now I will need a hysterectomy - my gynecologist says that I am in a bad position." He is in agreement with Fought that the Patch gave her the blood clot. It may also have contributed to her needing a hysterectomy.
There have been criticisms and warnings about the patch and its serious side-effects for the past several months from many experts including the consumer watchdog group [Public Citizen]
So why has it taken so long for the manufacturer Ortho McNeil, a Johnson and Johnson subsidiary, to take action?
Its regulators always maintained—up until now—that the patch was associated to risks similar to those of the oral birth control pill. On its packaging, Ortho Evra states that the possible Ortho Evra birth control patch side effect risks include: breast changes, headaches, nausea, menstrual changes, vaginal discharge, and abdominal cramps and bloating. But according to the [University of Michagan Adult Health Advisor] other serious risks may include the following problems:
ï¿½ blood clots in the arteries, veins, lungs, or brain
ï¿½ heart attack
ï¿½ brain hemorrhage (stroke)
ï¿½ gallbladder disease
ï¿½ tumors in the liver or breast cancer
ï¿½ eye problems (such as double vision or blood clots).
Ortho Evra Latest News
The Associated Press reported ( November 9th, 2005) that parents of a 14-year-old girl who died last year are suing Ortho-McNeil Pharmaceutical for failing to warn people sooner about serious side effects from using their birth control patch. Alycia Brown died of blood clots after using Ortho Evra, the lawsuit said. Last week, the company began warning users about this potential side effect. A company spokeswoman declined comment.
Ortho Evra Birth Control Patch Statistics
Studies in 2005 concluded that Ortho Evra Patch:
ï¿½ triples a woman's risk of developing a fatal blood clot or deep vein thrombosis (DVT).
ï¿½ side effects and the risk of death resulting in blood clots or deep vein thrombosis (DVT) was three in every 200,000 women.
The FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals, is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.