Period-Free Birth Control Pill Approved

Some Docs Say It's Safe; One Researcher Says More Study's Needed On Long-Term Safety

(CBS/AP)  The first birth control pill meant to put a stop to women's monthly periods indefinitely has won federal approval, the manufacturer said Tuesday.

Called Lybrel, it is 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.

Doctors studying the new pill say it's no riskier than the traditional pill, reports CBS News correspondent Michelle Miller.

Dr. Anne Davis led a clinical trial on the drug.

"What women need to know about Lybrel that makes it different from other pills is that you take it every day," Davis tells Miller. "There's no week off as there is with traditional birth control pills."

But medical researcher Linda Andrist would like to see more studies on its long-term safety.

"We don't know about bone health, breast cancer, heart disease, strokes, especially for young women," said Andrist.

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 Wyeth pill is the first designed to put off periods altogether when taken without break.

The FDA planned a late-afternoon news conference to announce approval.

Wyeth plans to start Lybrel sales in July. The Madison, N.J., company said it hasn't yet determined a price. The pill contains a low dose of two hormones already widely used in birth-control pills, ethinyl estradiol and levonorgestrel.

Most of the roughly 12 million U.S. 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 tests, 59 percent of women who took the medication had no bleeding after six months.

However, 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth. That sort of unanticipated and irregular bleeding can be a problem with low-dose pills.

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. Why medicate away a normal life event if we're not sure of the long-term effects?" said Elson, who researches the sociology of gender and medical sociology.

In recent years, as the hormone content of birth-control pills has dipped, failure rates have climbed. The FDA is mulling 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.

[egmd]

FDA approved or not, I wouldn't let my wife touch this pill with a nine-foot pole.

[shanev137]

Great. I guess that means the country will be less psychotic and more peaceful now.

[juliemd]

Too bad...I always thought of the monthly period as a good cleansing...kinda like blood on the battlefield of life...worth fighting for; tie a yellow ribbon for; like a good surge...

[jakih1108]

These pills are no different from any other birth control pill already on the market. The only difference is instead of taking a placebo week-the week you get your period-you take pills with hormones. And the period is not a cleanse for the female body. The monthly period is meant to removed the build up of lining in the uterus. Take any hormonal birth control prevents the build up of this lining to begin with so the monthly period that is experienced while on the pill is not a true period.

[only_child-2009]

I'd be afraid to try this. I can see big problems 10-20 years down the road. That's about how long it will be before some serious problems start popping up.

[jakih1108]

Women have been taking hormonal birth control to skip their periods for decades. Many doctors have prescribed continuous birth control to help with menstrual migraines, I have been taking the pill continuously to prevent the monthly migraine. This is not a new technology, it's simply a new marketing technique. Now, they can market a pill to prevent menstruation even though women have been doing it for years.

[mdc76082]

"We don't know about bone health, breast cancer, heart disease, strokes, especially for young women," said Andrist.

Yeah, you might have been doing it for years, but I'm sure curtailing natures isn't healthy. If it was meant to happen during life, I'm sure that's the way nature intended it to be. CBS. You better get ready in about 5-10 yrs. I am sure there will be some LOOOOOOOOOOOOONG TERM problems coming up that'll be making the news.

[norshatakaha]

I hope it doesnt just stop the menstration, I hope it stops the hormonal bursts also.

[hypnotoad72]

Where are the fundies talking about God's will and all?

More to the point, will this drug be given to people in high population nations? Seems more humane than selective abortions...

[reel-crazy]

Since I am a man, I'll come back in 8 years before I make any comment...

[michellem99-2009]

Be careful ladies. I am 52. I went thru the the change of life at 37. I hated the periods. After everything shut down, as I am weak. I use to be strong not after the change. I can't lift a gal. of water now. Age 36 ,I could. I never took meds to to stop the monthies. They stopped.
This pill to to be truthful,I would not trust it. They have no idea what these differents meds will do the human body so that raises the red flag.
I am just a lay person. So the new meds the Drs. write for this or that don't know the pros and cons of every drug. I don't dutifully take a Dr.'s word as gospel truth.FDA pandering to the special interest bunch,soulds like to me.

[antoniof123]

Reel-Crazy I agree with you I am a man and to tell you the truth I don't have to worry about it so I am not even going go give my opinion. although it was a well written peice.

[susanhelit]

Dying of old age at 35-40 is natural, children with no living grandparents is natural, broken bones refusing to heal, dying of diabetes - lots of things are natural. I'm no big worshipper of that. Yeah, sometimes medicines go wrong - but they also do plenty of wonderful things.

[johnshaft4]

I want to know what is in for me and my fellow man...WILL THIS END PMS?!

[incog-nito]

These pills may have serious side-effects years from now, but one thing you can be certain: those were very, very good years.

[johnshaft4]

Did anyone bother to get Falwell to sign off on this before he checked out to make certain that Jesus approves?

[galaxiana]

This is unnatural and harmful to a woman's homeostasis, the balance that nature gives her body. Every month that a woman doesn't menstruate, the lining in her uterus thickens a little bit, with the result that women who take these pills for several years without stop will suffer extremely painful periods upon cessation, and probably a much higher chance of miscarraige and abbreviated term pregnancy. The whole point of menstruation is to shed the lining of the uterus when pregnancy does not occur.

Our bodies evolved over time immemorial to function in the certain ways that they do, and artificially stopping these marvelous natural cycles, especially for long periods of time, will lead to grievous harm for the women who do so. All this risk of harm, and for what? So a major drug company can turn a profit?

I really wonder who the FDA is looking out for, when I see unnecessary drugs like this being approved for the "convenience" of women at the expense of their overall homeostasis and well-being.

[kirk0518]

what happens if a woman decides she wants to become pregnant, will the pill have an effect on that?..

[ecuadoriana]

Why are women so ready to give over their bodies to a drug company's profit pocket & with all the drugs the FDA approved that have been found to be more harm than good!

A pill that stops mentruation? Good grief. This was designed for men because a woman's cycle is an inconvenience to him! A rite of passage into womanhood is her menstruation but men have their sick preoccupation with all things pre-pubescent- from suckling on (mamma's) teats to wanting women to be shaved completely clean & looking anorexic. Recently I read where women get the skin around their anuses "lightened" to be more attractive. Huh?! In that case, why doesn't he go find himself a boyfriend & let you women find yourselves one of the last real men out there who will love & appreciate all aspects of your being, all phases of your cycle, all the reasons you are a woman! They're out there ladies (I have one! My husband feels that my period is good "down time", giving us time to talk & refresh our friendship w/each other. No, he's not for hire!).

That women are buying into this control pill shows how far we have NOT come- women still allow themselves to be enslaved, controlled & defined by what our bodies mean to men. We are not live-in porn stars or s-x machines.

This isn't a medication prescribed to women who suffer severe dibilitating illness during their periods, it's designed to shut down what makes her a woman.

What next? A 2 for 1 special- Viagra for him & Lybrel for her?

[vermonter52]

The FDA doesn't really have a good track record does it? Just look at all the pills they have approved that have now have been pulled from the market due to side affects. FDA is in it for the money. What problem are you trying to solve with this pill? I would discourage anyone from being a guinea pig again for the FDA on this pill. The women's monthly period is normal, why fool with mother nature.

[barbaraf4]

"I want to know what is in for me and my fellow man...WILL THIS END PMS?!"
Posted by JohnShaft4 at 11:38 PM : May 22, 2007

As far as I know, PMS didn't exist until about 25 years ago, when the pharmaceutical companies put a name on it so they could sell drugs to controll it.

We used to have bloating, cramps, fatigue and mood swings (hope I'm not too clinical). Then PMS became an accepted behavior. It became an excuse to really be a b*tch, whether you were suffering the symptoms or not. I worked for a manager who apparently suffered from PMS all month long - at least that was her excuse for her rude, b*tchie behavior 24/7.

This new medication may or may not stop PMS, but I assure there are many, many more listed in the pharmacopoeia that do control it.

If not, when your significant other is having a difficult month, then give her a kiss and tell her you love her (whether it's true or not at that moment). Afterall, she puts up with your antics all month long.

[a-ji]

Need further test must be done. Anything that are artificially made has bad side effects, may not be notice on early years but definitely it will come at old age. Ladies, lets be extra careful with this one. Monthly period may be that annoying at times but its one way knowing that we are still capable of having a child.

[barbaraf4]

"Monthly period may be that annoying at times but its one way knowing that we are still capable of having a child."
Posted by A-JI at 10:08 AM : May 23, 2007

Not so. It is possible to have a period without ovulating.

[ecuadoriana]

"As far as I know, PMS didn't exist until about 25 years ago, when the pharmaceutical companies put a name on it so they could sell drugs to controll it." Posted by barbaraf4 at 09:40 AM : May 23, 2007

You are so right on, barbaraf4!!! Before the label "PMS" we just dealt with it, took a mydol, took a nap. In high school (in the cave age 1970s) we were encouraged to participate in gym class & found that physical activity really did help alleviate the symptoms- even if it was to take our minds off it for 45 minutes!

Ever since woman insisted on enslaving themselves to an office desk all day, where they get no physical activity, it's no wonder their symptoms worsened! So of course, there was a doctor waiting on the sidelines to prescribe a pill (cha-ching!) & women readily gobbled them up & enjoyed labeling themselves with a syndrome or excuse (my latest favourite: fibromyalgia. GET UP & GET MOVING!).

When JohnShaft4 asked: "I want to know what is in for me and my fellow man..." he epitomised the school yard/locker room mentality of most ignorant men whose blood flows forever downstream because there's nothing upstream worth hanging around for. He thinks it's all about him & his needs & his wants- which he always wants at his convenience. A man like that should invest in a blow up doll & leave women alone.

[phoenix1218]

Unless you know someone who has it I would not write it off as just another pain people come up with. Did people deal with it before, sure, are you right to a point ecuadoriana, yes, but I hope you get some "made up" pain and see how you deal with it. Then, maybe you will not be so quick to judge others who have "made up" pain.

~fibromyalgia~
1) A syndrome characterized by chronic pain in the muscles and soft tissues surrounding joints, fatigue, and tenderness at specific sites in the body. Also called fibromyalgia syndrome, fibromyositis, fibrositis. Inflammation is absent, and the cause is unknown.

[oleander8]

"It isn't nice to fool Mother Nature"

Any women who jump on this bandwagon are foolish in the extreme.

[ecuadoriana]

"... and the cause is unknown..." Posted by Phoenix1218 at 10:37 AM : May 23, 2007

But they sure do have a lot of medications for it! Everything from anti depressants to muscle relaxants! All of them coming with a price tag.

"Well, Mrs. Syndrome, you sure do have a lot of unexplained aches & pains. Of course my grandpa did too, but he just kept on working & lived to be a ripe old age, I digress. Of course I sympathyse with the fact that this is probably interfering with the quality of your life. I'd feel depressed, too, if I felt all achey while sitting around watching American Idol & Dancing with the Stars every night. And it hurts when you chew? Oh you poor thing! So tell ya' what, I'm going to write you a prescription... (cha-ching!)"

Oh course when the side effects of the medications kick in then there's a medication for the side effects too! What a drug dependent country we've become! And we complain that Columbia is pushing it's drugs on us! Please! We ARE the market. The people of the US are all legal drug addicts!!!

[ecuadoriana]

"... and the cause is unknown..." Posted by Phoenix1218 at 10:37 AM : May 23, 2007

But they sure do have a lot of medications for it! Everything from anti depressants to muscle relaxants! All of them coming with a price tag.

"Well, Mrs. Syndrome, you sure do have a lot of unexplained aches & pains. Of course my grandpa did too, but he just kept on working & lived to be a ripe old age, I digress. Of course I sympathyse with the fact that this is probably interfering with the quality of your life. I'd feel depressed, too, if I felt all achey while sitting around watching American Idol & Dancing with the Stars every night. And it hurts when you chew? Oh you poor thing! So tell ya' what, I'm going to write you a prescription... (cha-ching!)"

Oh course when the side effects of the medications kick in then there's a medication for the side effects too! What a drug dependent country we've become! And we complain that Columbia is pushing it's drugs on us! Please! We ARE the market. The people of the US are all legal drug addicts!!!

[a-ji]

"Monthly period may be that annoying at times but its one way knowing that we are still capable of having a child."
Posted by A-JI at 10:08 AM : May 23, 2007

Not so. It is possible to have a period without ovulating.

Posted by barbaraf4 at 10:12 AM : May 23, 2007

Really? Is isn't a fact that monthly periods were due to unfertilized eggs? What do you mean by "period without ovulating" is this really possible? Please barbaraf4 explain further, I just can't believe it! I would apprecite it, if you could elaborate on this one, thanks!

[juliemd]

May be the end of PMS, but men will still have their UMS--UGLY MOOD SWINGS!!!

To suggest women are the only ones prone to emotionality is ignoring the grumpy guy in the cubicle next to mine...!!

[barbaraf4]

Really? Is isn't a fact that monthly periods were due to unfertilized eggs? What do you mean by "period without ovulating" is this really possible? Please barbaraf4 explain further, I just can't believe it! I would apprecite it, if you could elaborate on this one, thanks!
Posted by A-JI at 12:56 PM : May 23, 2007
~~
Source: WebMD

What causes dysfunctional uterine bleeding?

Normally one of your ovaries releases an egg during your menstrual cycle. This is called ovulation. Most women who have dysfunctional uterine bleeding get it when their ovaries don't release an egg. This causes changes in hormone levels and in some cases can lead to unexpected vaginal bleeding.

~~

Also, for the record, you can get pregnant without having periods. Just ask any woman who has ever gotten pregnant during the time she was nursing an infant.

[michellem99-2009]

I was in high school in the early 70s and this girl in our class felt like the odd one. She never had her first period and she was 16.The rest of us girls did. She wanted that rite of passage so bad. I have no idea if she ever did.
The thing is today this nation would rather medicate everybody from children ,teen,young,middle, and old adults. Control of the person by the medical,state,govt,families,schools, and the like. They had a saying in the 60s*don't trust anyone over 30*.Today we had no faith in anything but a pill or lots of them.
I don't don't trust the FDA, the doctors ,lawyers,or any one bent on greed,control, the like.

[a-ji]

I see, thanks a lot barbaraf4 for that informative data!

[agnim]

Gosh, I hate blood of any kind and hate even more to discuss what is strictly PRIVATE 'woman thingy'; but these lost and mindless scientists with too much time and devilishness on their hands are always seeking to undermine the species with their childish experimentations.

When the well being of the species is endangered, then it becomes everybody's 'thing'.

Hopefully the wiser women will know to continue being women, teach their daughters to emulate them, and not seek to become some mad scientist freak of nature with this misguided and evil invention.

[barbaraf4]

"Hopefully the wiser women will know to continue being women, teach their daughters to emulate them, and not seek to become some mad scientist freak of nature with this misguided and evil invention."
Posted by Agnim at 03:02 PM : May 23, 2007

Well said!!

[demetrius81]

This is radiculous!!! This is another way to undermind people. It gives people the (excuse)to have unprotected *** with multi partners, and not have to worry about having a child from those persons. How great is that. Not. Having a period is a part of nature. I am a male an will never experience that part of life. But I was born with a brain and over the years I have gain common sense. If you are a woman considering this pill, then I feel totally sorry for you.