Do Not Use the Ortho Evra Birth Control Patch
November 14, 2005 15:19

From Joan Claybrook & Frank Clemente
FOR IMMEDIATE RELEASE

Statement of Dr. Sidney Wolfe, Director of Public Citizen?s Health Research Group

Washington, DC--More than two months ago, we warned readers of our online Web site, www.WorstPills.org, and the 180,000 readers of our Worst Pills, Best Pills newsletter not to use the dangerous new birth control patch, Ortho Evra (Ortho-McNeil), because of the increased risk of life-threatening blood clots in people using this product. (For the full text of this warning, go to www.WorstPills.org.)

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.

Contraceptives are prescribed to younger, mainly healthy women and should be associated with the lowest possible risk of serious adverse drug reactions. Blood clots in the lungs were seen in two women given Ortho Evra in clinical trials conducted before the drug was approved (in addition to an increasing number of similar cases in women after the drug was marketed), and there is no evidence that the patch is a more effective contraceptive compared to older, second-generation birth control pills.

The FDA medical officer who reviewed the drug before approval, in addition to differing with the company about the evidence for increased blood clots, also expressed concern that 211 of 3,088 women (6.8 percent) in pre-approval clinical trials gained 10 or more pounds. He also noted that the contraceptive effectiveness of Ortho Evra was reduced in women weighing more than 198 pounds.

There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.

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Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

FDA notified healthcare professionals and patients of revisions to the label for Ortho Evra, a skin patch approved for birth control, that includes a bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.

The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.

It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.

Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.

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 total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximal blood level of estrogen (peak blood levels) is about 25% lower with Ortho Evra than with typical birth control pills. While the estrogen level with the patch remains constant for one week until the patch is removed, the peak blood levels with a daily birth control pill rapidly declines to levels that are lower than on the Orthro Evra.

FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.

The new labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm.