Dangerous Drugs, Medicines and Medical Devices
Ortho Evra Patch Update
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New Research Findings and Latest Label Warnings for Birth Control Patch

The maker of the birth control patch Ortho Evra has now issued two warnings (one on February 16, 2006, and the most recent September 25, 2006) that women who use the patch face three times the risk of developing blood clots than those that take the pill. This comes on the heels of the Food and Drug Administration issuing a warning on November 10, 2005 that patch users are being exposed to a higher dose of hormones, and therefore are at a higher risk of blood clots and other serious side effects.

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Side effects associated with the Ortho Evra® Patch:

  • DVT (Deep Venous Thrombosis)
  • PE (Pulmonary Embolism)
  • Blood Clots
  • Heart Attack
  • Stroke
  • Death

Until recently, patch-maker Ortho McNeil (a subsidiary of Johnson & Johnson) had claimed that the patch exposed users to the same risks as the most common birth control pills found on the market. In response to the November FDA warning, Ortho McNeil added a strongly worded warning to the patch label saying women using the patch would be exposed to almost 60 percent more estrogen than those using typical birth-control pills.

The warnings by Ortho McNeil and the FDA recognize the increased dangers of using the drug, which were noted by the FDA physician who reviewed the drug before the agency approved it. In addition to differing with the drug company about the evidence for increased blood clots, the FDA physician also expressed concern that 211 of 3,088 women (6.8 percent) in pre-approval clinical trials gained 10 or more pounds. Despite these facts, the agency still allowed the drug on the market and is stubbornly unwilling to ban it.

Since Ortho EvraŽ went on sale in April 2002, the contraceptive patch has been aggressively marketed to consumers and doctors as a convenient alternative to oral birth control pills. Approximately 4 million women have used the patch since it went on sale in 2002.

The manufacturers of the Ortho Evra patch have begun settling some claims for injuries linked to the patch. We believe Ortho McNeil may attempt to settle many other serious injury claims before the end of this year. Deadlines for bringing claims are fast approaching. If you or a loved one has been injured, contact us now.

Your time to collect compensation for your serious injury may be short. If you, a family member or someone you know has been injured, contact us today for a free, private consultation. Knowledge is Power. Let Us Help You Get The Compensation You Deserve.


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