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 FDA Approves Contraceptive for Continuous Use

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PostSubject: FDA Approves Contraceptive for Continuous Use   Thu Sep 20, 2007 11:52 pm

FDA Approves Contraceptive for Continuous Use


ROCKVILLE, MD -- May 22, 2007 -- The Food and Drug Administration (FDA)
today 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.
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