Despite the late warning by the FDA, the patch has not been taken off the market! Will more women suffer the agony of blood clots like Maria Urenda and Hillary Burris?
Why has it taken so long, so many serious injuries and even fatal deaths for the makers of Ortho Evra to warn consumers?
Ortho McNeil, a Johnson and Johnson subsidiary, in conjunction with the FDA, finally issued a warning regarding the increased risks of blood clots associated with Ortho Evra. And just a few weeks ago it stated on the patch label that women are exposed to about 60 percent more estrogen than those using most other birth control pills.
To this day, Ortho Evra is sold to countless consumers and the manufacturer markets its product aggressively to family planning clinics and physicians.
Here are two women's accounts of serious injuries and near-fatal deaths due to Ortho Evra
Maria Urenda, Cottage Grove, Oregon. Age: 28
"I started taking Ortho Evra in late 2004. I asked the Planned Parenthood clinic about possible side effects and they said it was the same as the pill. So I tried one box and didn't like it; it made me dizzy. So I discontinued it.
About three weeks later, I noticed that my legs were bruised but it was weird because I hadn't bumped into anything. I didn't pay much attention until a few weeks later: bruises were all over my hands and neck. I went to my primary care physician and asked her about it. And if I scratched myself, lots of bumps would appear along with the bruises.
She told me to get blood tests that same day. Later that evening, I got a call from the clinic, asking if I felt OK. The doctor at the clinic said if I wasn't feeling good or started bleeding anywhere to go to emergency right away."
The clinic also called her interpreter (Urenda's first language is Spanish) and explained that Urenda's platelets were dangerously low.
"When [my interpreter] explained it to me, I cried all night and thought I might die. I have two kids and I was so worried.
Next day I went to my physician and she sent me to a cancer specialist. He put me on prednisone right away and I went there every few days to check my blood. Later they did a biopsy, and a bone marrow test, thinking that I had cancer. I waited a week and the results came back negative. Now they were talking about removing my spleen. The doctor prescribed prednisone.
I was so stressed out so my family took me on a trip to Mexico. But when I got there my leg had swollen. Two days later it was even bigger and really hot. The doctor in Mexico advised surgery. I panicked and bought the first plane ticket back to Eugene, Oregon. I went to ER at Sacred Heart Hospital. The attending doctor said it couldn't be a blood clot with such low platelets.
I had a second opinion and this time another doctor said it was possible. I had an ultrasound and there was a clot in my vein."
Urenda's doctor said that her blood clot most likely was caused by the patch.
Hilary Burris, Springfield Illinois. Age 21
"I was prescribed the patch in summer 2004 at my local clinic. When I talked to my doctor about it, she said it wasn't that big a deal; there was only a risk for women over 35 and if I smoked.
I hadn't been on it more than six months when I was rushed to emergency. My leg was swollen to twice its size. My Mom had to come over in the middle of the night with crutches to help me get out of bed.
When I went into ER I was asked if I was on any medications. As soon as I said the patch, the doctor told me to take it off right away.
The doctor at the hospital told my Mom that he suspected a blood clot. Sure enough, an ultrasound showed a clot in my upper inner thigh. I was hospitalized and had injections in my stomach every 12 hours along with pain killers - the pain was excruciating. It hurt to sit on the toilet, I couldn't sleep and I was really scared because the doctor told me that if the clot broke loose it could go to my heart or lung and I could die.
My Mom had to take time off work and look after me when I got home. I had to get constant tests to make sure my blood wasn't too thick and I was on blood thinners."
By the time Burris returned to work, three months later, she was no longer needed. It took a few more months to find a job. Today she feels OK. " But if I know of anyone who is taking the patch, I tell them to take it off--now," says Burris.
As for Maria Urenda , she had never been sick, not a day in her life. She had no medical insurance to cover deductibles, and this has been an unexpected major financial strain on her family.
Over four million women have used the patch since the FDA's approval in November, 2001. A recent lawsuit alleges that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks.
Furthermore, The Associated Press used the Freedom of Information Act to obtain adverse drug reaction reports for Ortho Evra from the FDA. They reported that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from last year.
The FDA estimates that it receives reports of only 1 in 10 to 1 in 100 of the serious adverse drug reactions that actually occur, indicating that the actual rate of death may be much higher.
The Associated Press further reports January 31, 2006, that, "an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was "too high a chance that study may not produce a positive result for Evra".