The Gazette (Colorado Springs), “Suit: Birth control to blame for brain clot”

           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.
          The lawsuit was filed in July in New Jersey, the headquarters of Johnson & Johnson and its subsidiary, Ortho McNeil, the patch's manufacturer.
          The suit claims the risk of suffering a blood clot is much higher with the patch than with the pill.
          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.
          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.