FDA approves world's first contraceptive skin patch
Tuesday, November 20th 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ Federal health officials approved sale of the world's first contraceptive patch Tuesday, giving women an option considered as safe and effective as the pill but easier for some to use.
Ortho-Evra emits through the skin low doses of the same hormones used in birth control pills _ but requires women to remember to use it weekly instead of daily like a pill.
Overall, ``it is very, very, very similar to the pill'' in preventing pregnancy, said Dr. Dena Hixon, a Food and Drug Administration medical reviewer.
But the FDA, in approving the matchbook-sized beige patch, warned that Ortho-Evra may not work as well for women who weigh more than 198 pounds.
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. That suggests the patch may not deliver enough pregnancy-preventing hormones to these heavier women, Hixon said.
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.
Contraception experts eagerly welcomed the long-awaited patch, the fourth new contraceptive option to win FDA approval in the last year.
The new trend is toward options that don't have to be used every day or directly before intercourse, said Dr. Vanessa Cullins, medical vice president for Planned Parenthood.
Those options include contraceptive injections taken every month or every three months, implants or IUDs that prevent conception for years at a time, and _ the most novel until Tuesday's approval _ a hormone-emitting contraceptive ring slipped into the vagina once a month.
But the patch is the easiest-to-use of these methods yet, Cullins said.
``You're just going to slap it on your skin,'' she said. ``It gives women more control ... and it's less invasive than other long-term methods.''
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.