Featured Research

from universities, journals, and other organizations

BIrth Control Pill That Stops Periods Approved By FDA

Date:
May 23, 2007
Source:
Food And Drug Administration
Summary:
The Food and Drug Administration (FDA) has approved Lybrel, the first continuous use drug product for prevention of pregnancy. It stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible.

The Food and Drug Administration (FDA) has approved Lybrel, the first continuous use drug product for prevention of pregnancy.

The new contraceptive, Lybrel, comes in a 28 day-pill pack with low-dose combination tablets that contain 90 micrograms of a progestin, levonorgestrel, and 20 micrograms of an estrogen, ethinyl estradiol, which are active ingredients available in other approved oral contraceptives. Continuous contraception works the same way as the 21 days on-seven days off cycle. It stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible.

Other contraceptive pill regimens have placebo or pill-free intervals lasting four to seven days that stimulate a menstrual cycle. Lybrel is designed to be taken without the placebo or pill-free time interval. Women who use Lybrel would not have a scheduled menstrual period, but will most likely have unplanned, breakthrough, unscheduled bleeding or spotting.

The safety and efficacy of Lybrel as a contraceptive method were supported by two one-year clinical studies, enrolling more than 2,400 women, ages 18 to 49. Health care professionals and patients are advised that when considering the use of Lybrel, the convenience of having no scheduled menstruation should be weighed against the inconvenience of unscheduled bleeding or spotting. The occurrence of unscheduled bleeding decreases over time in most women who continue to take Lybrel for a full year. In the primary clinical study, 59 percent of the women who took Lybrel for one year had no bleeding or spotting during the last month of the study.

Like other available oral contraceptives, Lybrel is effective for prevention of pregnancy when used as directed. The risks of using Lybrel are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attacks, and strokes. The labeling also carries a warning that cigarette smoking increases the risk of serious cardiovascular side effects from the use of combination estrogen and progestin-containing contraceptives. Birth control pills do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Because Lybrel users will eliminate their regular periods, it may be difficult for women to recognize if they have become pregnant. Women should take a pregnancy test if they believe they may be pregnant. Women should also discuss contraceptive use, and the precautions and warnings for use of the drug product, with their doctors or other health care professional.

The approval of Lybrel concludes a comprehensive review process that included expert advice from a meeting of an FDA's Reproductive Health Drugs advisory committee and an opportunity for public comment on issues regarding hormonal contraception.

Lybrel is manufactured by Wyeth of Philadelphia, PA.


Story Source:

The above story is based on materials provided by Food And Drug Administration. Note: Materials may be edited for content and length.


Cite This Page:

Food And Drug Administration. "BIrth Control Pill That Stops Periods Approved By FDA." ScienceDaily. ScienceDaily, 23 May 2007. <www.sciencedaily.com/releases/2007/05/070523073028.htm>.
Food And Drug Administration. (2007, May 23). BIrth Control Pill That Stops Periods Approved By FDA. ScienceDaily. Retrieved September 22, 2014 from www.sciencedaily.com/releases/2007/05/070523073028.htm
Food And Drug Administration. "BIrth Control Pill That Stops Periods Approved By FDA." ScienceDaily. www.sciencedaily.com/releases/2007/05/070523073028.htm (accessed September 22, 2014).

Share This



More Health & Medicine News

Monday, September 22, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Sierra Leone in Lockdown to Control Ebola

Sierra Leone in Lockdown to Control Ebola

AP (Sep. 21, 2014) Sierra Leone residents remained in lockdown on Saturday as part of a massive effort to confine millions of people to their homes in a bid to stem the biggest Ebola outbreak in history. (Sept. 20) Video provided by AP
Powered by NewsLook.com
Sierra Leone's Nationwide Ebola Curfew Underway

Sierra Leone's Nationwide Ebola Curfew Underway

Newsy (Sep. 20, 2014) Sierra Leone is locked down as aid workers and volunteers look for new cases of Ebola. Video provided by Newsy
Powered by NewsLook.com
Changes Found In Brain After One Dose Of Antidepressants

Changes Found In Brain After One Dose Of Antidepressants

Newsy (Sep. 19, 2014) A study suggest antidepressants can kick in much sooner than previously thought. Video provided by Newsy
Powered by NewsLook.com
Could Grief Affect The Immune Systems Of Senior Citizens?

Could Grief Affect The Immune Systems Of Senior Citizens?

Newsy (Sep. 19, 2014) The study found elderly people are much more likely to become susceptible to infection than younger adults going though a similar situation. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins