No Period Birth Control Pill Gets FDA Approval
Featured ArticleMain Category: Women's Health / Gynecology
Also Included In: Pregnancy / Obstetrics; Pharma Industry / Biotech Industry
Article Date: 23 May 2007 - 0:00 PDT
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The US Food and Drug Administration (FDA) has given approval to the first continuous use, "no period" birth control drug Lybrel (made by Wyeth). This means women will be able to take the pill continuously with no scheduled menstrual period every four weeks, as happens with other currently available oral contraceptives. However, there is a much greater chance that they will have unplanned breakthrough bleeding, or spotting.
Lybrel works in the same way as the "21 days on, 7 days off" oral contraceptives by preventing ovulation and stopping the body preparing for pregnancy.
It comes in a 28-day pack of pills each containing a low dose combination of the same two active ingredients: a progestin, levonorgestrel (90 micrograms), and an estrogen, ethinyl estradiol (20 micrograms). The only difference is that instead of 7 of the 28 days being a placebo or pill free day, the patient continues to take a the active ingredients throughout, hence no scheduled menstrual cycle.
Lybrel was approved on the evidence of two clinical trials lasting one year and involving more than 2,400 women aged 18 to 49 to test the safety and effectiveness of the drug.
The safety and efficacy study was published in the December 2006 issue of the journal Contraception.
One of the results of the trials was to suggest that the frequency of unscheduled bleeding or spotting most likely decreases the longer a woman is on the continuous use pill. In the primary study 59 per cent of the women who took the drug for a year had no bleeding or spotting in the final month.
According to the manufacturer, studies showed that Lybrel did not delay a return to fertility nor did it affect return to normal menstruation.
Like other oral contraceptives Lybrel is only effective if used as directed and it has similar side effects. These include: increased risk of blood clots, heart attacks and strokes. The product carries a label warning pointing out that women who take the combination pill have an increased risk of serious cardiovascular problems if they also smoke cigarettes.
The FDA points out that because Lybrel has no scheduled menstrual cycle, women will find it more difficult to tell if they have become pregnant.
When considering the use of Lybrel, women and their doctors should weigh up the convenience of no regular menstruation against the inconvenience of unpredictable spotting or breakthrough bleeding. This is in addition to the usual discussion about benefits and risk factors and how they might apply in their own situation, including any contraindications (for instance incompatibility with existing medication) and what other options are available, as with any treatment.
The manufacturer is continuing with post marketing studies of thromboembolic events among women taking Lybrel compared to women on cyclic oral contraceptives containing 20 mcg ethinyl estradiol.
As with any contraceptive pill, Lybrel offers no protection against infection by sexually transmitted diseases (STDs) or HIV.
Lybrel is expected to be in US pharmacies in July 2007 and will be available by prescription only.
Combined oral contraceptives were first approved for use in the US in 1960.
Around 100 million women all over the world use this form of birth control, with nearly 12 million of them in the US.
Worldwide usage varies enormously, and some of the differences are probably cultural. For instance in Japan, only 1 in 100 women aged 16 to 49 use the pill, whereas in the UK the figure is 1 in 4.
Click here for FDA.
Written by: Catharine Paddock
Writer: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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Visitor Opinions In Chronological Order (4)
Birthcontrol Bill
posted by Holly on 23 May 2007 at 8:54 amI think women are supposed to have a period, that's the way it is supposed to be. Only doing a study for one year will NOT show you the results of what will happen to a women's body after years and years of not having a period. It can lead to so many problems why can't people see that. Is life so demanding that a women can't take out 3-5 days a month to flush out the body's natural cycle. IT"S WRONG!
Periods Aren't Necessarily Natural
posted by Janine on 13 Jun 2007 at 9:16 pmMy mother endured 15 pregnancies because at the time no doctor would prescribe the pill to a Catholic woman and all the doctors in the small town were Catholic (50s to early 60s).
By all accounts she had no period for well over 15 years of her 30 chidbearing years. She is an extremely healthy 85 yr old woman. Our bodies were not designed to never get pregnant. So birth control in and of itself is not natural under this same line of thinking as your's Holly.
It's one thing to diet yourself so thin you don't have a period due to lack of hormone regulation. it's another thing to maintain a hormone cycle that precludes periods for a while. I don't think this is a good longterm solution for young women, but if you're a 35+ athlete whose had your kids or doesn't plan to have any, trying to climb Mt Everest, without having to deal with a period and all its uncomfortable side effects in base camp and while climbing over 45 days sound really really smart to me.
i have not had a period!
posted by heather on 27 Sep 2010 at 2:40 pmIs there any way you can get pregnant on the pill? I take it everyday at the same time! I didn't have my period like I normally do, concerned what should I do? Keep taking the pill and hope for a change this month or should I get a doctors visit?
Is It Time?
posted by jyner on 30 Jan 2011 at 6:57 pmIs it time that the people should accept this bill? Coz for me the population is rapidly increasing that is why many people suffered hunger. Hunger leads to crime, crime leads to death? T_T
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