FDA approves first pill meant to end periods
Lybrel halts cycle when taken without break; will go on market in July
NBC video
Updated Video Birth control — the next generation
May 22: Today's approval by the FDA of the drug Lybrel heralds the next generation of birth control pills. NBC's Nancy Snyderman reports.
WASHINGTON - The first birth-control pill meant to put a stop to women’s monthly periods indefinitely won federal approval Tuesday.
Called Lybrel, it’s the first such pill to receive Food and Drug Administration approval for continuous use. When taken daily, the pill can halt women’s menstrual periods indefinitely and prevent pregnancies.
Lybrel is the latest approved oral contraceptive to depart from the 21-days-on, seven-days-off regimen that had been standard since birth-control pill sales began in the 1960s. The pill, manufactured by Wyeth, is the first designed to put off periods altogether when taken without break.
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The pill isn’t for everyone, an FDA official said. About half the women enrolled in studies of Lybrel dropped out, said Dr. Daniel Shames, a deputy director in the FDA’s drugs office. Many did so because of the irregular and unscheduled bleeding and spotting that can replace scheduled menstruation.
“If you think you don’t want to go down this road, this is not for you,” Shames told reporters.
Wyeth plans to start Lybrel sales in July. The Madison, N.J., company said it hasn’t yet determined a price for the 28-pill packs. The pill contains a low dose of two hormones already widely used in birth-control pills, ethinyl estradiol and levonorgestrel.
A study showed Lybrel was just as effective in preventing pregnancy as a traditional pill, Alesse, also made by Wyeth. However, since Lybrel users will eliminate their regular periods, it may be difficult for them to recognize if they have become pregnant, Shames said.
Click for related content
New Vote: Is it a good idea to halt menstrual periods indefinitely?
Most of the roughly 12 million American women who take birth-control pills do so to prevent pregnancy. Others rely on hormonal contraceptives to curb acne or regulate their monthly periods.
Some nontraditional pills such as Yaz and Loestrin 24 shorten monthly periods to three days or less. Seasonique, an updated version of Seasonale, reduces them to four times a year. With Lybrel, in one test, 59 percent of the women who took Lybrel for a year had no bleeding or spotting during the last month of the study. However, because of dropouts, that translates into only about one-third of all the women originally enrolled in the study, Shames said.
Want to skip your period?
New hormonal contraceptives on the U.S. market give women multiple ways to skip or shorten their periods:
—Seasonique comes in packs with 84 active birth control pills and seven dummy pills, so it limits periods to every three months. Launched last August, it works the same as predecessor Seasonale, which got cheaper generic competition in September. Made by Duramed of Barr Pharmaceuticals Inc. of Woodcliff Lake, N.J., Seasonique adds estrogen to the dummy pills to reduce breakthrough bleeding and menstrual symptoms.
—Yaz, made by Bayer HealthCare Pharmaceuticals of Wayne, N.J., is a low-estrogen contraceptive with 24 days of active pills and four blank ones. Launched last August, it offers shorter, lighter “periods,” milder cramps and prevention of severe PMS.
—Loestrin 24, launched in April 2006, also has 24 active pills and four blank ones. Made by Warner Chilcott Inc. of Rockaway, N.J., it can shorten periods to three days or less and reduce the level of bleeding.
—Implanon, a flexible, matchstick-size rod inserted in the upper arm, stops menstruation in some women but makes it irregular in others. Approved last July, it works for up to three years and contains only progestin, an option for women avoiding estrogen for medical reasons. Maker Organon USA Inc. of Roseland, N.J., says it has sold 3.2 million units worldwide so far.
Some older methods also can eliminate periods:
—Mirena, also made by Bayer, is an intrauterine device that prevents pregnancy for up to five years, reduces monthly bleeding by 90 percent in most women and eliminates bleeding in about 20 percent after a year.
—Depo-Provera, an injection containing progestin but no estrogen, generally prevents menstruation after several months in many women. Now available in generics, it works for three months. Long-term use may thin bones.
Other options are on the horizon. Bayer is testing another oral contraceptive with an extended, flexible dosing schedule and Duramed is developing a lower-estrogen version of Seasonique.
Associated Press
“Women who use Lybrel would not have a scheduled menstrual period, but will most likely have unplanned, breakthrough, unscheduled bleeding or spotting,” Shames said. The bleeding can last four to five days and may persist for a year, he later added. Women who take other low-dose pills have reported similar issues.
Still, a women’s health expert said Lybrel would be a welcome addition for the woman who seeks relief from the headaches, tender breasts, cramps and nausea that can accompany monthly periods. Whether Lybrel relieves those symptoms was not directly studied.
“Over time she will experience markedly less bleeding episodes or no bleeding episodes,” said Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America Inc. “That is very beneficial for some women — and is wanted by some women.”
‘Menstruation is a normal life event’
University of New Hampshire sociologist Jean Elson pointed to advantages for what she characterized as a small number of women who suffer extraordinarily during menstruation, but overall she said the pill left her with mixed feelings.
“For women in that situation, I certainly can understand the benefits of taking these kinds of medications, but for most women menstruation is a normal life event — not a medical condition,” said Elson, who researches the sociology of gender and medical sociology. “Why medicate away a normal life event if we’re not sure of the long-term effects?”
In recent years, as the hormone content of birth-control pills has dipped, failure rates have climbed. The FDA is considering whether to establish an acceptable failure rate for the pills. In January, a panel of agency advisers said less-effective birth-control pills should still merit federal approval if they promise other benefits, including improved safety.
Generally, lower-dose birth-control pills can reduce the risk of serious and sometimes deadly side effects, including blood clots and stroke, associated with their use.
The injectable hormonal contraceptive Depo-Provera also can eliminate monthly periods.
Lybrel halts cycle when taken without break; will go on market in July
NBC video
Updated Video Birth control — the next generation
May 22: Today's approval by the FDA of the drug Lybrel heralds the next generation of birth control pills. NBC's Nancy Snyderman reports.
WASHINGTON - The first birth-control pill meant to put a stop to women’s monthly periods indefinitely won federal approval Tuesday.
Called Lybrel, it’s the first such pill to receive Food and Drug Administration approval for continuous use. When taken daily, the pill can halt women’s menstrual periods indefinitely and prevent pregnancies.
Lybrel is the latest approved oral contraceptive to depart from the 21-days-on, seven-days-off regimen that had been standard since birth-control pill sales began in the 1960s. The pill, manufactured by Wyeth, is the first designed to put off periods altogether when taken without break.
Story continues below ↓advertisement
The pill isn’t for everyone, an FDA official said. About half the women enrolled in studies of Lybrel dropped out, said Dr. Daniel Shames, a deputy director in the FDA’s drugs office. Many did so because of the irregular and unscheduled bleeding and spotting that can replace scheduled menstruation.
“If you think you don’t want to go down this road, this is not for you,” Shames told reporters.
Wyeth plans to start Lybrel sales in July. The Madison, N.J., company said it hasn’t yet determined a price for the 28-pill packs. The pill contains a low dose of two hormones already widely used in birth-control pills, ethinyl estradiol and levonorgestrel.
A study showed Lybrel was just as effective in preventing pregnancy as a traditional pill, Alesse, also made by Wyeth. However, since Lybrel users will eliminate their regular periods, it may be difficult for them to recognize if they have become pregnant, Shames said.
Click for related content
New Vote: Is it a good idea to halt menstrual periods indefinitely?
Most of the roughly 12 million American women who take birth-control pills do so to prevent pregnancy. Others rely on hormonal contraceptives to curb acne or regulate their monthly periods.
Some nontraditional pills such as Yaz and Loestrin 24 shorten monthly periods to three days or less. Seasonique, an updated version of Seasonale, reduces them to four times a year. With Lybrel, in one test, 59 percent of the women who took Lybrel for a year had no bleeding or spotting during the last month of the study. However, because of dropouts, that translates into only about one-third of all the women originally enrolled in the study, Shames said.
Want to skip your period?
New hormonal contraceptives on the U.S. market give women multiple ways to skip or shorten their periods:
—Seasonique comes in packs with 84 active birth control pills and seven dummy pills, so it limits periods to every three months. Launched last August, it works the same as predecessor Seasonale, which got cheaper generic competition in September. Made by Duramed of Barr Pharmaceuticals Inc. of Woodcliff Lake, N.J., Seasonique adds estrogen to the dummy pills to reduce breakthrough bleeding and menstrual symptoms.
—Yaz, made by Bayer HealthCare Pharmaceuticals of Wayne, N.J., is a low-estrogen contraceptive with 24 days of active pills and four blank ones. Launched last August, it offers shorter, lighter “periods,” milder cramps and prevention of severe PMS.
—Loestrin 24, launched in April 2006, also has 24 active pills and four blank ones. Made by Warner Chilcott Inc. of Rockaway, N.J., it can shorten periods to three days or less and reduce the level of bleeding.
—Implanon, a flexible, matchstick-size rod inserted in the upper arm, stops menstruation in some women but makes it irregular in others. Approved last July, it works for up to three years and contains only progestin, an option for women avoiding estrogen for medical reasons. Maker Organon USA Inc. of Roseland, N.J., says it has sold 3.2 million units worldwide so far.
Some older methods also can eliminate periods:
—Mirena, also made by Bayer, is an intrauterine device that prevents pregnancy for up to five years, reduces monthly bleeding by 90 percent in most women and eliminates bleeding in about 20 percent after a year.
—Depo-Provera, an injection containing progestin but no estrogen, generally prevents menstruation after several months in many women. Now available in generics, it works for three months. Long-term use may thin bones.
Other options are on the horizon. Bayer is testing another oral contraceptive with an extended, flexible dosing schedule and Duramed is developing a lower-estrogen version of Seasonique.
Associated Press
“Women who use Lybrel would not have a scheduled menstrual period, but will most likely have unplanned, breakthrough, unscheduled bleeding or spotting,” Shames said. The bleeding can last four to five days and may persist for a year, he later added. Women who take other low-dose pills have reported similar issues.
Still, a women’s health expert said Lybrel would be a welcome addition for the woman who seeks relief from the headaches, tender breasts, cramps and nausea that can accompany monthly periods. Whether Lybrel relieves those symptoms was not directly studied.
“Over time she will experience markedly less bleeding episodes or no bleeding episodes,” said Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America Inc. “That is very beneficial for some women — and is wanted by some women.”
‘Menstruation is a normal life event’
University of New Hampshire sociologist Jean Elson pointed to advantages for what she characterized as a small number of women who suffer extraordinarily during menstruation, but overall she said the pill left her with mixed feelings.
“For women in that situation, I certainly can understand the benefits of taking these kinds of medications, but for most women menstruation is a normal life event — not a medical condition,” said Elson, who researches the sociology of gender and medical sociology. “Why medicate away a normal life event if we’re not sure of the long-term effects?”
In recent years, as the hormone content of birth-control pills has dipped, failure rates have climbed. The FDA is considering whether to establish an acceptable failure rate for the pills. In January, a panel of agency advisers said less-effective birth-control pills should still merit federal approval if they promise other benefits, including improved safety.
Generally, lower-dose birth-control pills can reduce the risk of serious and sometimes deadly side effects, including blood clots and stroke, associated with their use.
The injectable hormonal contraceptive Depo-Provera also can eliminate monthly periods.
