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 23, 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 23, 2014).

Share This



More Health & Medicine News

Tuesday, September 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Costs Keep Mounting

Ebola Costs Keep Mounting

Reuters - Business Video Online (Sep. 23, 2014) The WHO has warned up to 20,000 people could be infected with Ebola over the next few weeks. As Sonia Legg reports, the implications for the West African countries suffering from the disease are huge. Video provided by Reuters
Powered by NewsLook.com
WHO: Ebola Cases to Triple in Weeks Without Drastic Action

WHO: Ebola Cases to Triple in Weeks Without Drastic Action

AFP (Sep. 23, 2014) The number of Ebola infections will triple to 20,000 by November, soaring by thousands every week if efforts to stop the outbreak are not stepped up radically, the WHO warned in a study on Tuesday. Duration: 01:01 Video provided by AFP
Powered by NewsLook.com
5 Ways Men Can Prevent Most Heart Attacks

5 Ways Men Can Prevent Most Heart Attacks

Newsy (Sep. 23, 2014) No surprise here: A recent study says men can reduce their risk of heart attack by maintaining a healthy lifestyle, which includes daily exercise. Video provided by Newsy
Powered by NewsLook.com
Liberia Pleads for Help to Fight Ebola

Liberia Pleads for Help to Fight Ebola

AP (Sep. 22, 2014) Liberia's finance minister is urging the international community to quickly follow through on pledges of cash to battle Ebola. Bodies are piling up in the capital Monrovia as the nation awaits more help. (Sept. 22) Video provided by AP
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:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

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