---------------------------------------------------------------------------- NEW YORK (Reuters Health) Nov 20 - The US Food and Drug Administration on Tuesday approved the first-ever transdermal hormone patch as a weekly form of birth control for women.
The Ortho Evra patch, developed by Ortho-McNeil, will be made and marketed by RW Johnson. Both businesses are part of Raritan, New Jersey-based Johnson and Johnson.
A one and three-quarter inch patch containing norelgestromin and ethinyl estradiol, Ortho Evra is designed to be an alternative to oral contraceptives. Once affixed, the patch offers regular transdermal delivery of the hormones for 1 week, RW Johnson said.
Ortho Evra is developed for application to the lower abdomen, buttocks, upper body or upper outer arm only, the firm noted. Each patch should be worn continuously for 7 days before being replaced with a new patch on the same day of the week.
The regimen should be followed for 3 weeks, with no patch being applied in the fourth week, Ortho Evra noted. As with oral contraceptives, the treatment-free week allows a woman to have her period.
The patch prevents pregnancy "when used as directed," RW Johnson emphasized. The hazards associated with its use are similar to those of oral contraceptives, including a greater risk of thrombosis, myocardial infarction and stroke. As with oral contraceptives, smokers are warned against using Ortho Evra due to an increased risk of serious cardiovascular side effects, the company noted.
In clinical trials comparing the patch to oral contraceptives, about 5% of women said that they had at least one patch fall off, while 2% stopped using Ortho Evra due to skin irritation, the firm said. Further, the patch was found to be less effective in women weighing over 198 pounds, the FDA noted.
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In Friendship Kath Findlay
The UK Adhesion Society
kath.findlay@adhesions.org.uk
http://www.adhesions.org.uk
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