Healthcare Industry News: estradiol
News Release - December 7, 2006
First and Only Chewable Birth Control Pill Now AvailableNew Spearmint-Flavored Femcon(TM) Fe Offers Convenient New Option for More Than 11 Million Women Using Oral Contraceptives
ROCKAWAY, N.J., Dec. 7 (HSMN NewsFeed) -- 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 www.wcrx.com.
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.
Source: Warner Chilcott
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