A: 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.

http://www.fda.gov/bbs/topics/NEWS/2007/
NEW01637.html
Lybrel Warnings

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.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01637.html


Ingredients in Lybrel

The oral contraceptive Lybrel contains 90 mcg levonorgestrel and 20 mcg
ethinyl estradiol
in each tablet as their active ingredient  for the prevention
of pregnancy in women who elect to use oral contraceptives and who have no
known contraindications for this method of contraception.  

Lybrel is the first and only low dose combination contraceptive pill taken 365
days a year, without a placebo phase or pill-free interval.  

Available by prescription, Lybrel is expected to be in U.S. pharmacies in
July
2007.


Use of Lybrel

Lybrel is intended for women who are seeking contraception and who are
interested in putting their menstrual cycle on hold.  

Lybrel provides a steady low dose of hormones so that over time women may
become cycle-free.  

Women considering Lybrel should know that most subjects in the clinical
studies experienced some breakthrough bleeding and spotting, especially
during the first three to six months.  

In studies and analyses, Lybrel did not delay a return to fertility nor did it
affect return to menses.

Lybrel is also indicated for the prevention of pregnancy in women who elect to
use oral contraceptives as a method of contraception.

Oral contraceptives are highly effective for pregnancy prevention.

The efficacy of contraceptive methods, except sterilization, the IUD, and
implants, depend upon the reliability with which they are used.

Correct and consistent use can result in lower failure rates.

Worldwide clinical trials involving 2,457 women demonstrated the efficacy of
Lybrel.  

Breakthrough bleeding and spotting were also evaluated and were shown to
lessen over time.

The bleeding pattern was categorized in clinical trials as breakthrough
bleeding that requires sanitary protection or spotting that did not require
sanitary protection.

  • 59 percent of women achieved amenorrhea (defined as absence of all
    bleeding and spotting)
  • 20 percent of women experienced spotting only, not requiring any
    sanitary protection
  • 21 percent of women required sanitary protection due to breakthrough
    bleeding

The Lybrel safety and efficacy study was published in the December 2006
issue of the journal Contraception.
http://www.wyeth.com/news
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