|
More FDA Resources
Ortho Evra®, Ortho McNeil Pharmaceutical's birth control patch, recenlty had labeling changed. The new label warns that women using Ortho Evra® are exposed to higher levels of estrogen compared to most birth control pills.
Women using the Ortho Evra® patch may be exposed to about 60% more estrogen on average than if she were taking a birth control pill containing a 35 microgram dose of estrogen. However, the highest levels of estrogen are about 25% lower with Ortho Evra® than with a traditional birth control pill.
Increased estrogen exposure may increase the risk of severe adverse events such as blood clots, heart attack, and stroke, but at this point it's not known whether women using Ortho Evra® have a higher risk of serious side effects than women taking traditional birth control pills. Ortho McNeil is conducting additional studies to examine this question.
Reference:
"Higher Estrogen Exposure with Ortho Evra Contraceptive Patch - FDA Patient Safety News: Show #47, January 2006", FDA, January 2006.
|
