To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Prescribing Information for Postmenopausal Hormone Therapies URL: http://www.pslgroup.com/dg/226D46.htm Doctor's Guide January 8, 2003
ST. DAVIDS, PA -- January 8, 2003 -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) has approved the prescribing information for its postmenopausal hormone therapy (HT) products Prempro™ (conjugated estrogens/medroxyprogesterone acetate tablets), Premphase® (conjugated estrogens/medroxyprogesterone acetate tablets), and Premarin® (conjugated estrogens tablets, USP). The approved labeling contains a boxed warning that highlights safety information previously incorporated elsewhere in bolded statements in Wyeth's prescribing information and adds a new statement that generalizes these findings to all postmenopausal HT products. The new labeling refines the product indications, but does not add any new safety findings. In August 2002, Wyeth unilaterally implemented interim labeling detailing the safety findings from the Women's Health Initiative (WHI) study. The boxed warning states that "Estrogens with or without progestins should not be used for the prevention of cardiovascular disease." It also brings forward risk information from other sections of the prescribing information. Specifically, it states that the WHI reported increased risks for heart attacks, strokes, invasive breast cancer, and blood clots in the lungs or legs. The FDA has determined that while other combinations of estrogens and progestins were not studied in WHI, in the absence of comparable data, the risks identified in the study should be assumed to be similar for all postmenopausal HT products. Estrogens or estrogens plus progestins should be prescribed at the lowest effective doses and for the shortest duration to accomplish treatment goals. "We have worked closely with the FDA to facilitate the communication of this important information, which reinforces the appropriate use of hormone therapy in postmenopausal women," says Victoria Kusiak, M.D., Vice President, Global Medical Affairs and North American Medical Director. "We believe it is in the best interests of patients and physicians that all manufacturers of HT products act quickly to modify their prescribing information." The prescribing information now states that when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk and non-estrogen medications should be carefully considered. In addition, the indication for postmenopausal vaginal atrophy now specifies treatment of moderate to severe symptoms. Further, when prescribing solely to treat the symptoms of vaginal atrophy, topical products should be considered. As it did in August 2002, the Company is sending revised prescribing information to over 550,000 physicians and other health care providers. The new FDA-approved prescribing information can be viewed on the Wyeth product websites -- http://www.premarin.com and http://www.prempro.com . Premarin, Prempro and Premphase, remain valuable treatments for symptomatic menopausal women. Postmenopausal HT is the only therapy proven both to relieve menopausal symptoms, including hot flashes, night sweats, and the dryness associated with vaginal atrophy, and to prevent postmenopausal osteoporosis. The decision to use hormone therapy should always be made on an individual basis after careful consideration of treatment goals, a woman's medical history, and all the known risks and benefits of hormone therapy. Product Information Premarin is approved for the treatment of moderate to severe hot flashes and night sweats associated with menopause, the treatment of moderate to severe vaginal dryness, and the prevention of postmenopausal osteoporosis. Prempro and Premphase are approved for women with an intact uterus for the treatment of moderate to severe hot flashes and night sweats associated with menopause, the treatment of moderate to severe vaginal dryness, and the prevention of postmenopausal osteoporosis. Premarin, Prempro, and Premphase are not approved and should not be used to prevent coronary heart disease. The use of estrogen alone in nonhysterectomized, postmenopausal women has been reported to increase the risk of endometrial carcinoma. Doctors may prescribe a progestin along with estrogen to reduce this risk. Because of the potential increased risk of heart attack, stroke, breast cancer, and blood clots, use of Premarin, Prempro, or Premphase should be limited to the shortest duration consistent with treatment goals and risks for the individual woman and should be discussed with her physician regularly. If Premarin, Prempro, or Premphase have been prescribed for the prevention of postmenopausal osteoporosis only, a different treatment or medicine without estrogens should be carefully considered. The most commonly reported side effects of Premarin are hair loss, headache, and weight gain. The most commonly reported side effects of Prempro and Premphase are postmenopausal bleeding, hair loss, and breast pain. Estrogens and estrogens/progestins combined should not be used under any of the following conditions or circumstances: known or suspected pregnancy; undiagnosed unusual vaginal bleeding; known, suspected, or past breast cancer; known or suspected estrogen-sensitive tumors; active venous or arterial thromboembolism (e.g., stroke, blood clots, or heart attack), or a history of these conditions; liver dysfunction or disease. Premarin, Prempro, and Premphase should not be used in patients hypersensitive to their ingredients. About Wyeth 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 that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing, and commercialization, and economic conditions, including interest and currency exchange rate fluctuations, the impact of competitive or generic products, product liability and other types of lawsuits, the impact of legislative and regulatory compliance and obtaining approvals, and patents, and other risks and uncertainties, including those detailed from time to time in Wyeth's periodic reports, including quarterly reports on Form 10-Q and the Annual Report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. SOURCE: Wyeth Pharmaceuticals --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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