Warner Chilcott
(Nasdaq: WCRX) announced today the availability of the first birth control
pill that offers women the option of chewing their daily tablet, called
Femcon(TM) Fe.
As the first and only FDA-approved chewable birth control pill, Femcon
Fe* is indicated for the prevention of pregnancy. The chewable version is
also designed to provide a convenient, new option for women "on-the-go"
taking oral contraceptives. Additionally, the active ingredients and doses
in Femcon Fe provide effective cycle control and may be a good choice for
women who are experiencing breakthrough bleeding with their current oral
contraceptive.
"Research has shown that compliance still impacts oral contraceptive
failure rates, and anything we can do to make it easier for our patients to
maintain a daily regimen is a notable advancement," said Laurent
Delli-Bovi, MD, Medical Director, Women's Health Services at Chestnut Hill
Family Planning Facility in Boston, Massachusetts. "We're excited to be
able to offer a chewable formulation to patients looking for convenience or
to those who may be experiencing problems on other pills, such as
breakthrough bleeding."
When taken correctly, oral contraceptives have a failure rate of less
than one percent per year. However, studies show that 47 percent of women
miss one or more pills per month and missing pills can increase the risk of
pregnancy.
"Women who rely on the birth control pill tend to lead busy lives and
have less time," said Roger Boissonneault, Chief Executive Officer of
Warner Chilcott, the company that markets Femcon Fe in the United States.
"We wanted to offer women a convenient, easy-to-use option for those
"on-the-go" with the same reliability as the traditional swallowed pill."
Femcon Fe contains the same active ingredients as found in other
combination oral contraceptives -- a progestin, norethindrone 0.4 mg, and
an estrogen, ethinyl estradiol 35 mcg. Available in a 28-day regimen, each
blister-package of Femcon Fe contains 21 round white tablets with
norethindrone and ethinyl estradiol, followed by seven "reminder" brown
(inactive) tablets to complete a four-week-cycle. The reminder tablets also
contain 75 mg of ferrous fumarate (iron). The pill may be chewed, followed
by a full glass of liquid, or swallowed whole.
Important Safety Information about Femcon Fe
Femcon Fe potential side effects are similar to those seen with other
progestin/estrogen combination oral contraceptives. Serious risks include
an increased risk of blood clots, heart attack and stroke. Cigarette
smoking by women, especially over age 35, increases the risk of serious
cardiovascular side effects from use of oral contraceptives. Oral
contraceptives do not protect against HIV infection (AIDS) or other
sexually transmitted diseases.
Women and healthcare professionals who would like to learn more about
Femcon Fe, including full Prescribing Information, should visit
wcrx.
About Oral Contraceptives' Widespread Use and Multiple Benefits
The first oral contraceptive pill was approved by the U.S. Food and
Drug Administration in 1960. Today, more than 11 million American women are
currently taking an oral contraceptive, and research shows that 80 percent
of all U.S. women born since 1945 have used the pill. When taken correctly,
oral contraceptives are 99 percent effective in preventing pregnancy.
Oral contraceptives may provide benefits other than prevention of
unintended pregnancy including protection against ovarian and endometrial
cancers, benign breast disease, pelvic inflammatory disease, ectopic
pregnancy, and iron-deficiency anemia. Improvement of dysmenorrhea,
irregular or excessive bleeding, acne and endometriosis-associated pain is
also associated with oral contraceptive therapy. Some experts also believe
that oral contraceptives may prevent functional ovarian cysts and reduce
the risk of different types of cancer.
About Warner Chilcott
Warner Chilcott is a leading specialty pharmaceutical company focused
on developing, manufacturing and marketing and selling branded prescription
products in women's healthcare and dermatology in the United States. WCRX-G.
Femcon Fe was formerly named Ovcon 35 Chewable, which was introduced
in September 2006.
Warner Chilcott
wcrx
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