Healthcare Industry News: estradiol
News Release - July 30, 2007
Lybrel, First Low Dose Combination Oral Contraceptive with Unique 365-Day Dosing, Now Available in U.S.COLLEGEVILLE, Pa., July 30 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that Lybrel(TM) (90 mcg levonorgestrel/20 mcg ethinyl estradiol tablets) is now available by prescription in U.S. pharmacies. Lybrel is indicated for the prevention of pregnancy and is the first and only low dose combination contraceptive pill taken 365 days a year, without a placebo phase or pill-free interval. Lybrel is priced comparably to other recently introduced brand name oral contraceptive products, packaged in the unique new ClickCase(TM) and can be found at most pharmacies.
"As a leader in women's health care, Wyeth is proud to be the first to provide women with a contraceptive option that allows many of them to put their monthly cycle on hold," says Ginger Constantine, M.D., Vice President, Women's Health Care, Wyeth Pharmaceuticals. "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."
The Pill does not protect against HIV or other sexually transmitted diseases.
Unscheduled bleeding or spotting is likely to occur while you are taking Lybrel. The convenience of having no regular menstrual periods should be weighed against the inconvenience of unscheduled or unplanned breakthrough bleeding and spotting.
Some women should not use the Pill, including women who have blood clots; breast, uterine, or liver cancers; a history of heart attack, stroke, or breast cancer; as well as those who are or may be pregnant.
Serious risks associated with the Pill which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes.
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use, especially if you are over 35. Women who use the Pill are strongly advised not to smoke.
Lybrel provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year) than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins.
Because regular monthly bleeding does not occur on Lybrel, it may be difficult to recognize if you get pregnant. If you suspect that you may be pregnant, or if you have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, you should have a pregnancy test and you should contact your health care professional.
The most common side effects reported with Lybrel in a clinical trial were headache, menstrual cramps, upper respiratory infection, vaginal bleeding, and nausea.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
For more information, visit http://www.Wyeth.com.
Source: Wyeth Pharmaceuticals
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