Safety Warning Issued For Ortho Evra Birth Control Skin Patch

FDA: Possible Increased Risk of Blood Clots For Ortho Evra Users

In November 2005 the FDA announced that it had approved an updated label, or package insert, for the Ortho Evra contraceptive patch.  The purpose of the label change was to warn doctors and patients that the Ortho Evra birth control patch exposes women to higher levels of estrogen than a typical birth control pill. In turn, because of the higher levels of estrogen, women using the Ortho Evra skin patch for birth control are at an increased risk of developing blood clots and other serious side effects.

The new label, or package insert for Ortho Evra, includes a bold-letter, or "bolded", warning about higher exposure to estrogen for women using the weekly patch compared to taking a typical birth control pill.

A November 10 FDA News Release gives us a summary of the blood clot problem associated with Ortho Evra:

The addition of this new warning is a result of FDA's and the manufacturer's analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills.

According to Dr. Sidney Wolfe, the Director of Public Citizen’s Health Research Group, the FDA's action is too late and too little:

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

Ortho McNeil is reportedly in the process of conducting additional drug-safety studies for Ortho Evra about the degree of increased risk for women using Ortho Evra patch -- in comparison to women using typical birth-control pills -- of developing blood clots and other serious side effects.

(Posted by: Tom Lamb)