Ortho Evra Birth Control Patch Found Dangerous
The U.S. Food and Drug Administration (FDA) recently acknowledged what experts have been saying for months: Ortho Evra (manufactured by Ortho-McNeil) birth control patches are dangerous. The agency warned that "women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill." Increased estrogen means increased risks, including the increased risk of life-threatening blood clots.
Ortho Evra was approved by the FDA in 2001 and was the first skin patch to be approved as a contraceptive product. According to Public Citizen, in 2004, "the drug accounted for more than 9.9 million prescriptions with sales topping $411 million."
The Ortho Evra patch contains two hormones, a progestin and an estrogen. The progestin is a new drug, norelgestromin, and the estrogen is ethinyl estradiol, an older estrogen. This combination has apparently led to serious, even fatal, consequences.
Ortho-McNeil and the FDA medical officer reviewing Ortho Evra disagreed about whether cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the drug. The medical officer wrote:
THE REVIEWER DOES NOT AGREE WITH THE SPONSOR'S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the ... group [emphasis in the original].
The medical officer also made the following comments:
The professional product labeling and information written specifically for women using Ortho-Evra "should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate) [emphasis in the original].
Despite the FDA's findings, it has not banned the patch. A comprehensive study done by Public Citizen, a national non-profit public interest organization, however, reports that "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."
We strongly urge women considering the use of birth control to consult with their physicians before taking any drug, including Ortho Evra.
To review the Public Citizen study, please click http://www.worstpills.org/public/newsletter.cfm?n_id=413