DANVILLE, Calif., April 21 /PRNewswire/ -- Ortho Evra is an adhesive, transdermal birth control patch. It is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.
Evidence shows that Ortho Evra is dangerous and should be recalled from the market. Studies found that women using the Ortho Evra birth control patch were twice as likely to develop blood clots compared with those using oral birth control pills.
As a result of these studies, The Food and Drug Administration updated Ortho Evra's warning language to reflect that women using the patch faced twice the risk of blood clots as women on the pill.
This is not the first time there have been changes made to the warnings about Ortho Evra's risks. The first warning about the increased risks of blood clots associated with Ortho Evra was issued on November 10, 2005. In that warning, Ortho-McNeil, one of the manufacturers of Ortho Evra, admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than those taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen.
It is alleged 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. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills.
The contraceptive patch continues to be aggressively marketed using Olympic athletes, sexy ads and fashion models despite having been linked to many deaths.
Approximately 4 million women have used the Ortho Evra Patch since it
went on sale in 2002. Doctors who reviewed the reports commented that they
were alarmed at the number of fatalities.
Side effects associated with the Ortho Evra Patch include:
-- DVT (Deep Venous Thrombosis) -- Heart Attack
-- PE (Pulmonary Embolism) -- Stroke
-- Blood Clots -- Death
The first fatality publicly blamed on the Ortho Evra patch came in April 2005, when an 18 year old Manhattan fashion student collapsed in a city subway station. An autopsy found a blood clot had moved into the victim's lung, and the medical examiner ruled that the clot was a side effect of the birth control device.
FDA records show that many patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots and possible strokes since August 2002. Regardless of it's link to life threatening diseases, the manufacturers of the Ortho Evra Patch have continued to aggressively market the patch as a convenient alternative to oral birth control pills.
The makers of the Ortho Evra Patch, Johnson & Johnson and Ortho-McNeil, are currently settling cases. Contact Alexander Hawes, LLP now for a free, private consultation. State laws may prohibit your time to pursue legal action. For more information please contact Alexander Hawes, LLP, toll free at (800) 511-3838 or go to http://www.ortho-evra-injury-lawyer.com.
|SOURCE Alexander Hawes, LLP|
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