In January 2008, the FDA changed the warning label on the package insert for the Ortho Evra Contraceptive Patch because of the overwhelming evidence that the patch was causing blood clots in women. Blood clots can result in deep venous thrombosis, hearth attacks, strokes, brain damage and death.
The FDA could no longer ignore the numerous cases filed against Johnson and Johnson, the manufacturer of Ortho Evra, despite its stubborn insistence by the manufacturer that the drug was safe.
Ortho Evra is a patch that delivers high doses of the hormones estrogen and progestin into a woman’s body through her skin in order to prevent conception and pregnancy. It is designed as an alternative to an oral medication. The hormone acts to prevent ovulation entirely, thus preventing conception and pregnancy.
Since Ortho Evra went on sale in April 2002, the contraceptive patch has been aggressively marketed to consumers and doctors. Approximately 4 million women have used the patch since 2002.
Women using the patch are exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen, according to the FDA.
The FDA‘s label changes followed a study by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women ages 15-44. These recent findings support other studies that report that women using the patch were at higher risk for VTE, or venous thromboembolism. One study showed that some women using the patch were at a two-fold greater risk of developing VTE. A two-fold increase is a significant scientific finding supporting proof that the Ortho Evra Patch causes clots responsible for strokes and heart attacks.
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