Nov. 11, 2005

Do Not Use the Ortho Evra Birth Control Patch

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

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.

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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