WASHINGTON -- American women may soon buy the world's first birth control in a skin patch.
The Food and Drug Administration approved Ortho-Evra on Tuesday, a patch that prevents pregnancy by emitting the same hormones used in birth-control pills. Studies found it is as safe and effective as the pill -- but women must remember to apply a patch just once a week as opposed to taking a pill every day.
The patch was eagerly awaited, the easiest-to-use method yet in the nation's trend toward longer-acting birth control, said one contraception expert.
"You're just going to slap it on your skin," said Dr. Vanessa Cullins, medical vice president of Planned Parenthood. "It gives women more control ... and it's less invasive than other long-term methods."
But the patch may not be a good option for every woman, the FDA cautioned. Women who weigh more than 198 pounds may not get a high enough contraceptive dose, said FDA medical reviewer Dr. Dena Hixon.
In clinical trials that gave 3,319 women the patch for varying amounts of time, 15 got pregnant -- and one-third of them weighed 198 pounds or more. Such women should discuss the patch versus other options with their doctors, Hixon advised.
Manufacturer Ortho-McNeil Pharmaceuticals said the patch would begin selling next year, by prescription only. The price will be similar to birth control pills, which cost about $40 a month.
Ortho-Evra is the fourth new contraceptive option to win FDA approval in the last year. The other new products include a monthly injection, a hormone-emitting IUD, and a hormone-emitting contraceptive ring slipped into the vagina once a month.
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