Ortho Evra: Too much Estrogen can be a Bad Thing

The makers of Ortho Evra are learning that there is such a thing as too much estrogen, as more and more lawsuits are being filed against them.

The latest lawsuit is a class action suit in Canada, filed July 28, 2006 in London, Ontario. At issue is the amount of the hormone estrogen that women who use Ortho Evra are exposed to. According to a news release from the Food and Drug Administration, women using Ortho Evra are exposed to as much as 60% more estrogen than those using a birth-control pill. Women on Ortho Evra are also three times as likely to suffer a blood clot as compared with women taking a birth-control pill.

The increased estrogen can lead to a number of serious side effects, including blood clots. These blood clots can enter the blood stream and block the flow of blood to the heart, brain, or lungs. The FDA reports that at least 12 women have died from such injuries. In addition to fatal injuries, many women have suffered from non-fatal venous thrombosis (blood clots in the veins of the legs).

In a 17 month period, the FDA received 9,116 reports of negative reactions to Ortho Evra. This is compared to Ortho Tri-Cyclen, for which the FDA received 1,237 negative reports in a six year period. It is estimated that Ortho Tri-Cyclen has six times as many users as Ortho Evra.

Significant Cases:

• A 46 year-old woman had a stroke after using Ortho Evra for three months.
  
  
• A 20 year-old woman suffered a pulmonary embolism after using Ortho Evra for six months.
  
  
• A 26 year-old woman died from acute pulmonary embolism after using Ortho Evra for just over seven months.
  
  
• A 14 year-old died after using Ortho Evra for eight weeks. She had a blood clot in her pelvis.
  
  
• A 19 year-old suffered two strokes after developing a 10-inch blood clot in her brain.

On November 10, 2005, the FDA announced it was changing the labeling of Ortho Evra to reflect the increased exposure to estrogen. The new labeling would include bolding to draw patients' attention to the warning.

Further complicating matters is that when Ortho Evra was first put on the market, its makers claimed it had the same amount of estrogen as birth-control pills. Some of the lawsuits, including the suit in Canada, claim that Ortho McNeil and parent company Johnson & Johnson knew about the increased medical risks but failed to warn patients about those risks. Those risks include blood clots, strokes, heat attacks, and deep vein thrombosis.

A lawsuit filed in a New Jersey Superior Court claims the Ortho Evra patch is "defectively designed" and "unreasonably dangerous." Women represented in the lawsuit range in age from 18-47 and come from all over the United States.

If you are concerned that you may have developed any of the negative side effects from using Ortho Evra contact your doctor immediately. He or she can advise you of what steps to take next.