Manu
11-21-2001, 01:53 PM
WASHINGTON (AP) -- 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 use it just once a week instead of daily.
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. They join other long-acting methods including Norplant, a contraceptive implant that lasts for years, and a once-every-three-months injection.
With Ortho-Evra, women would use one patch a week for three weeks, and then go patch-free for a week for their menstrual period.
Each patch should be applied to the lower abdomen, buttocks or upper body -- pick a slightly different spot each week, the FDA advised. Never put it on the breasts, the agency warned.
The patch is designed to stick to skin despite bathing or swimming. But if one slips off and won't restick, Ortho-McNeil will sell packages of single replacement patches.
If a patch falls off for more than a day, start a new four-week cycle of patches and use a backup method of contraception for the first week, the FDA advised. In studies, about 5 percent of women had at least one patch that slipped off.
The FDA was convinced the patch would prove reliable, citing one study where 90 percent of patch users properly replaced it once a week compared with 80 percent of women who remembered to take a birth control pill every day.
The patch delivers continuous low levels of estrogen and progestin, the same hormones found in birth control pills, to prevent ovulation. That means the patch carries the same risks as the pill: short-term side effects including nausea or breast tenderness, and rare risks of blood clots, heart attack and stroke, particularly if women smoke while using the contraceptive.
Also, Ortho-Evra users may experience skin irritation at the patch site.
www.cnn.com
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 use it just once a week instead of daily.
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. They join other long-acting methods including Norplant, a contraceptive implant that lasts for years, and a once-every-three-months injection.
With Ortho-Evra, women would use one patch a week for three weeks, and then go patch-free for a week for their menstrual period.
Each patch should be applied to the lower abdomen, buttocks or upper body -- pick a slightly different spot each week, the FDA advised. Never put it on the breasts, the agency warned.
The patch is designed to stick to skin despite bathing or swimming. But if one slips off and won't restick, Ortho-McNeil will sell packages of single replacement patches.
If a patch falls off for more than a day, start a new four-week cycle of patches and use a backup method of contraception for the first week, the FDA advised. In studies, about 5 percent of women had at least one patch that slipped off.
The FDA was convinced the patch would prove reliable, citing one study where 90 percent of patch users properly replaced it once a week compared with 80 percent of women who remembered to take a birth control pill every day.
The patch delivers continuous low levels of estrogen and progestin, the same hormones found in birth control pills, to prevent ovulation. That means the patch carries the same risks as the pill: short-term side effects including nausea or breast tenderness, and rare risks of blood clots, heart attack and stroke, particularly if women smoke while using the contraceptive.
Also, Ortho-Evra users may experience skin irritation at the patch site.
www.cnn.com