Case Evaluation

Ortho Evra Patch : Blood Clots and Deaths Associated with Ortho Evra Patch

On Thursday, November 10, 2005, Johnson and Johnson issued a warning saying that women who use the Ortho Evra birth control patch will be exposed to 60% more estrogen then those using standard forms of birth control. Following the warning, The Food and Drug Administration approved an updated label for the Ortho Evra contraceptive patch to warn patients about the exposure to higher levels of estrogen. The new warning clearly states that women who use the Ortho Evra birth control patch are exposed to about 60% more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen.

The Ortho Evra patch is linked with an increased risk of DVT (Deep Venous Thrombosis) and PE (Pulmonary Embolism), which can lead to stroke, hemorrhage, heart attack and death. Evidence shows that the risk of blood clots and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in phase III trials of Ortho Evra was six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestral.

This warning comes after the Food and Drug Administration has received twenty-one reports of life-threatening blood clots and other ailments associated with Ortho Evra birth control patch use. The contraceptive patch, manufactured by Ortho-McNeil, has been aggressively marketed to consumers and doctors as a convenient alternative to oral birth control pills. Approximately 4 million women have used the Ortho Evra Patch since it went on sale in 2002. Earlier this year The Associated Press reported that patch users die and suffer blood clots at a rate three times higher than women taking the pill.

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