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November 2005: FDA Approves Label Change For Ortho Evra Birth Control Patch

Higher Estrogen Levels Than The Pill Cause Increased Risk of Blood Clots For Women Using Ortho Evra Patch

In November 2005 the FDA approved an updated label, or package insert, for the Ortho Evra birth control patch. The new language includes a bolded warning which states that a woman who uses the Ortho Evra skin patch is exposed to about 60 percent more estrogen than if, instead, she was taking a typical birth control pill containing 35 micrograms of estrogen.

On November 10, 2005 the FDA issued a press release to alert doctors and patients of this Ortho Evra warning label change. The primary message was that a woman's exposure to the higher levels of estrogen released by the Ortho Evra birth control patch can cause an increased risk of developing blood clots and other serious side effects.

However, as explained by Dr. Sidney Wolfe, the Director of Public Citizen’s Health Research Group, it seems as if the FDA's action is too little, too late:

"The new warning by the U.S. Food and Drug Administration (FDA) belatedly acknowledges the increased dangers of using the drug. These dangers were noted by the FDA physician who reviewed the drug before the agency approved it. Despite the fact that the agency has now admitted that “women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill” - important because increased estrogen means increased risks - the agency still allowed the drug on the market and is stubbornly unwilling to ban it."

The Ortho Evra contraceptive skin patch has been used by more than five million women for birth control since it was approved by the FDA in 2002. "The Patch", as it is referred by many women, is made by Ortho-McNeil Pharmaceutical, Inc., which is a unit of the drug company Johnson & Johnson.

Soon after the November 2005 label change, Ortho McNeil and Johnson & Johnson announced that they were conducting additional studies for Ortho Evra intended to determine the degree of increased risk of developing blood clots for women using Ortho Evra skin patch, in comparison to a typical birth-control pill.

Read more on our Ortho Evra Information Page >>

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