FDA approves period suppression pill

  1. FDA approves period suppression pill

    By ANDREW BRIDGES, Associated Press Writer Tue May 22, 7:59 PM ET

    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.
    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.
    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.
    "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."
    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.

  2. why does this just not sound like a good thing to do to your body? I think of menstruation like a "self cleaning oven"...(sorry for that visual but I couldn't think of anything else...)
  3. This doesn't seem healthy to me....I know having a monthly period can be a PITA but come on! It's a natural bodily function. I don't get why women these days make such a big deal about it.
  4. I've actually been waiting for something similar to this to be available. As I don't have and don't want children, I have no use for periods, anyway. LOL If they had a pill that would shut down my entire reproductive system I'd consider taking it.
  5. Saw that on the news tonight. Very interesting. THis is my 2nd pregnancy in three years (babies will be 19 months apart) and I breastfed baby #1 until she was about 11 months old. I haven't ben on the pill in about 4 years and I haven't had many periods either. I don't even really remember what that whole thing (bc pills/periods) is like! LOL
  6. From my own experience, my period is a big PITA. I would take this because some months I get excruciating cramps, heavy heavy bleeding where I have had to wear a tampon and pad, backaches, nausea, etc. Sometimes I can't even get out of bed. It's no walk on the beach for me.
  7. I can only speak from experience; but, 10 years on the period suppressing Depo-provera put me into early menopause. I cannot tell you how painful the past year has been as I have tried to regain the working body of a woman in her early thirties! (last depo shot was 15 months ago after my bone density scan revealed moderate osteopenia)

    IMHO any drug (like depo) that stops periods CANNOT have good long-term consequences. I got my period for the first time in 13 years last month - I gained 10 pounds of water weight for 10 days....however, it was the BEST 10 days I have had in a REAL long time.

    I guess my point is to think long and hard of the REAL long-term consequences of a drug that supresses your menstrual cycle. Ask any and all questions from your doctor and understand that sometimes you just shouldn't screw with mother-nature.
  8. I think this is good news for people like me who get such terrible migraines due to a drop in estrogen right before our periods. Although, I'm going to wait a couple of years to see what happens, to ensure it's safe, with this pill.
  9. ITA. children are not a factor in my life so i would have no problem with taking it. in the Uk only about half of the drugs you have in the US are available so i coubt i will ever get a chance to try it.
  10. I'm with you caxe! I don't have periods anymore anyway- for the past few years I've been taking the pill continuously (no weeks with the "empty" pills) and it is heaven. I am much less worried about accidentally becoming pregnant, and I no longer suffer from the depression, bloating, painful cramps, headaches, fatigue that I used to. Why should we suffer if we don't have to? Lots of medicines that we take aren't "natural"- taking a pill to preventing pregancy isn't natural either. I have had no problems whatsoever health-wise, and my doctor says it's perfectly fine. But I will certainly keep up with the info from the science community regarding any possible long-term effects.
  11. This is absolutely AWFUL if you ask me. Seriously, the people behind these pills must not be thinking of long term effects. Do you know how estrogen dominant your body will become? Which can and will lead to early Menopause, awful menopause, and possibly a huge list of other complications such as tumors, cancer, growths, etc.

    This is absolutely awful that in this day and age modern medicine thinks something like this is right. Wait until people see the problems that come from this.

    The female body is intended to menstruate every month... there is a reason it does that.

    This really makes me sick
  12. I've been taking BC pills for about 10 years now and I double up packs so I only get my period every 2 months. My doctor also says this is perfectly fine.

    I'm not sure I'd be comfortable eliminating my period altogether but that's just a personal choice. If I got terrible headaches, cramps, nausea, etc. from my period though then I'd probably be singing a different tune.

    In any case, I'd definitely wait a couple years to see if anyone experiences any major side effects from it.
  13. i dont think that never having ur period is a good thing, the period is a natrual cycle for a woman to stop it compeltly would seem unnatrual to me.. there are many side effects int he long run like ppl mentioned.. u also reallly lose ur sex drive after a while i heard

  14. YES!!! Honestly, after I hit chemical menopause I had no sex drive - honestly, I didn't even think about it EVER - hard to explain unless you have experienced it. Read below though, after all - depo-provera is the drug used in the chemical castration of male sex-offenders.

    These drugs have unintended consequences - the doctors don't know what will happen long tern because there are no long-tern studies to refer to.

    I started Depo when it was offered only in "trials". Meaning I signed a waiver, and got the shots for free for 2 years - NO ONE told me what a horrible drug it was - perhaps the fact that they castrate male sex-offenders with Depo should have told me to get the F*** off it - but, I stayed on it - for WAY too long.

    Anyway - I have no experience with this new "wonder" drug but I cannot caution you ladies enough to stay away from anything that stops menstruation until there is enough evidence to support a claim of NO ILL-Side-effects.
  15. i have the most wonderful doctor and she says that in the past women didnt have monthly periods. if you go back a hundred years 2 or 3 periods a year was a common cycle, itts because of the chemicals we are exposed to now that cycles are so short and i have tri-cycled for a few years now (one period every 3 months)it works for me.