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 fas
|SOURCE Alexander Hawes, LLP|
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