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.

[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.

[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!!

[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.

[a-ji]

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

[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.

[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.

[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...!!

[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!

[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!!!