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The manufacturer has production of the device “due to a business decision,” according to information on the Food and Drug Administration (FDA) website.1 William Foster, spokesperson for Janssen Pharmaceuticals, confirmed the move in the following statement: “Janssen Pharmaceuticals has decided to discontinue its birth control patch Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) in the United States. A generic version of the contraceptive patch is now available, and if women have questions about transitioning to this generic alternative, or to other forms of birth control, they should speak with a health care provider.” Prescriptions decreased from five million in 2006 to about 1.3 million in 2010.2 Patch use might have fallen off with concerns about its use and risk of venous thromboembolism (VTE). Since Ortho Evra was approved in 2001, its labeling has been edited to address issues relating to VTE risk and exposure to contraceptive hormones seen with Ortho Evra as compared to certain combined oral contraceptives.
Rewind to 2002: The first transdermal contraceptive, the Ortho Evra patch, hit U.S. pharmacy shelves. Fast forward to the present: The manufacturer has production of the device “due to a business decision,” according to information on the Food and Drug Administration (FDA) website.1
William Foster, spokesperson for Janssen Pharmaceuticals, confirmed the move in the following statement: “Janssen Pharmaceuticals has decided to discontinue its birth control patch Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) in the United States. A generic version of the contraceptive patch is now available, and if women have questions about transitioning to this generic alternative, or to other forms of birth control, they should speak with a health care provider.”
Under Section 506C of the Federal Food, Drug, and Cosmetic Act, companies are required to notify the FDA of a permanent discontinuance of certain drug products six months in advance, or as soon as practicable. Projections indicate that product inventory of the Ortho Evra patch was set to deplete at distribution centers at the end of October 2014.
As of Contraceptive Technology Update press time, no information about the discontinuation had been posted on the Janssen Pharmaceuticals’ web site; the company still lists the Ortho Evra patch under its current list of products. There also is no indication of the discontinuation of the product on its dedicated web site, www.orthoevra.com.
Family planners do have an option for transdermal contraception. Mylan of Pittsburgh announced in April 2014 it had received FDA approval to market a generic version of the Ortho Evra patch. The patch, trademarked as Xulane, delivers a daily dose of 150 mcg of norelgestromin and 35 mcg of ethinyl estradiol through its transdermal system, the same formulation as in the Ortho Evra product.
Mylan is familiar with transdermal delivery of medicines. It was the first company to receive approval for generic nitroglycerin, estradiol, and fentanyl transdermal systems. It also produces transdermal clonidine and aided in the development of EMSAM (selegiline transdermal system), which it now manufactures.
A check of the web site, www.goodrx.com, shows that estimated cash prices for one package (three patches) of Xulane at area Atlanta drug stores range from $106 to $125, while estimated cash prices for one package of Ortho Evra (three patches) range from $126 to $158. Be sure to check local pharmacies to see if Xulane is stocked.
News of the Ortho Evra patch discontinuation might not prove to be a problem for some providers. Patch use has dropped, According to results of past CTU Contraception Surveys, 93% of respondents in 2005 said their facility provided the method as a contraceptive option; by 2013, 70% said they provided the patch. National prescription numbers for Ortho Evra reflect the decline. Prescriptions decreased from five million in 2006 to about 1.3 million in 2010.2
Patch use might have fallen off with concerns about its use and risk of venous thromboembolism (VTE). Since Ortho Evra was approved in 2001, its labeling has been edited to address issues relating to VTE risk and exposure to contraceptive hormones seen with Ortho Evra as compared to certain combined oral contraceptives. In March 2011, the boxed warning label was edited to include information about the potential risk of VTE and the pharmacokinetics profile of ethinyl estradiol associated with the use of Ortho Evra, which made it more prominent to healthcare providers.
1. Food and Drug Administration. FDA drug shortages. Accessed at http://1.usa.gov/12z5XZZ.
2. Associated Press. Ortho Evra birth control patch has higher blood clot risks but should remain on the market: FDA. NY Daily News 2011; http://nydn.us/1vHz0l.
Copyright AHC Media LLC Feb 2015