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COLORADO SPRINGS, Colo. - Not long after Amanda Bianchi began using a birth-control patch, she started getting incapacitating headaches, numbness in her hands and ringing in her ears.
An MRI revealed a 6- to 8-inch blood clot in her brain.
In July, the Colorado Springs woman and nine others from across the nation filed suit against the maker of Ortho Evra, claiming they suffered "substantial physical injuries" from using the contraceptive patch.
The suit claims the patch is "unreasonably dangerous," that risk disclosures on the product label are inadequate and that the chances of suffering a blood clot are much higher with the patch than with birth-control pills.
Bianchi, 20, who graduated from Air Academy High School in 2004 and whose family lives on the academy grounds, began using the patch a couple of months after graduation. She said she got a prescription to regulate her menstrual cycle.
Her symptoms started just weeks later, in September, with headaches so severe that for two weeks, she made almost daily visits to the emergency room at the Air Force Academy Hospital, said her mother, Deborah Bianchi.
Bianchi said she was in a critical-care unit for three weeks after the clot was detected.
Doctors immediately suspected the clot might be associated with the contraceptive patch, said Deborah Bianchi.
"Right away they said it was one of the possibilities," she said.
The lawsuit was filed in July in New Jersey, the headquarters of Johnson & Johnson and its subsidiary, Ortho McNeil, the patch's manufacturer.
Michael Beckerich, spokesman for Ortho Women's Health/Ortho-McNeil Pharmaceutical, said last month that the company does not comment on ongoing litigation. It did, however, issue a general statement:
"When used as labeled, Ortho Evra is a safe and effective birth control choice for many women," the statement said. "The safety of the patients who use our products is our first priority and we take all adverse event reports seriously. We investigate every report of a serious adverse event and closely monitor for any trends in reports that may signal a potential safety issue."
Amy Clark-Meachum, an attorney with the Austin, Texas, law firm that filed the suit, claims the patch is not as safe as oral contraceptives.
"At the very least, women need to know if they're going to use the patch over the pill, it's a riskier product," Clark-Meachum said. "While it might be more convenient for their lifestyles, it's also more dangerous."
The suit claims the risk of suffering a blood clot is much higher with the patch than with the pill.
The Associated Press also analyzed federal drug-safety reports and reported that in 2004, when 800,000 women used the patch, the risk of dying or suffering a major clot was three times that of women using birth-control pills. The news agency found information on about a dozen women who died last year from clots thought to be associated with the patch.
The patch, usually worn on the abdomen or buttock, is changed weekly for a three-week cycle; pills are taken daily. The patch went on the market in April 2002, and its manufacturer says it's been used by 4 million women.
From April 2002 through September 2003, the Food and Drug Administration logged 9,116 reports of adverse reactions from the patch, according to the suit.
"By way of comparison, the leading oral contraceptive, Ortho Tri-Cyclen, which during 2003 was used by almost six times as many women as the Patch, only generated 1,237 adverse reports to the FDA over a six-year period from November 1997 through September 2003," the suit reads.
The lawsuit also says that from May 1, 2002, until a year later, there were 44 reports to the FDA of serious clot-related injuries or deaths, compared with 17 such reports during the same time period for the pill Ortho Tri-Cyclen, even though the pill was used by almost six times as many women.
In addition to Bianchi, the other women listed as plaintiffs in the suit are:
-A 25-year-old woman, who had a blood clot in her right calf.
-Women ages 25, 26, 31, 42 and 43 who had clots in their lungs.
-A 47-year-old who suffered a stroke as a result of a clot;
-An 18-year-old and a 34-year-old who each suffered a brain clot.
Bianchi said her life has been put on hold since the clot was found almost a year ago.
She had to quit cosmetology school and takes blood thinners and pain medication. Her mother said she spends three or four days each week in bed. Her parents got her a Welsh corgi puppy to keep her company.
"I'm not in school. I can't drive," she said. "I don't have any normal activities. I'm scared. I love children. Am I even going to be able to have kids? I don't know what's going to happen in the future.
"I want other women to have an informed decision when they use the patch and know all the risks," she said.
(c) 2005, The Gazette (Colorado Springs, Colo.). Distributed by Knight Ridder/Tribune News Service.