MADISON, N.J., April 25 /PRNewswire-FirstCall/ -- On October 6, 2005, Wyeth filed a petition with the U.S. Food and Drug Administration (FDA), asking the agency to address the growing trends of unlawful manufacture and marketing of so-called bio-identical hormone replacement therapies (BHRTs). Wyeth has been increasingly concerned by the risks these products may pose to women's health.
Wyeth's petition to the FDA asks the agency to take action against only those pharmacies that are unlawfully promoting, manufacturing and selling unapproved drugs under the guise of "compounding," which poses a substantial risk to women's health and safety. Wyeth supports women's access to appropriately labeled and lawfully compounded medications. Wyeth's petition does not attack the traditional pharmacy practice of compounding, as some have suggested. Wyeth's petition does not oppose the legitimate compounding of customized medicines to meet individual patient medical needs as part of a physician prescription, nor does it oppose the traditional pharmacy practice that states regulate.
Bio-identical hormone replacement therapies, sometimes characterized as "natural" hormones, actually use chemicals synthesized from plants or other sources. It is important to know that these products are chemicals that are formulated in a laboratory. Unfortunately, these so-called BHRTs are often marketed to women as safer or more effective alternatives to FDA-evaluated and approved medications, even though BHRT products are not natural and have not been tested for safety or effectiveness.
In the wake of the Women's Health Initiative study findings, women with concerns about hormone therapies have frequently become targets for unproven BHRT products that certain pharmacies are promoting as safer and/or more effective alternatives to FDA-approved products. In fact, there is no scientific evidence to support these claims, and no FDA-required safety information is consistently provided to these women. As a result, many women are confused about the risks associated with treating their menopause symptoms. Wyeth believes that it is necessary for FDA to take action so that each woman can fully understand the risks associated with all hormone therapies and make an informed decision, in conjunction with her physician, about the treatment that is best for her.
Wyeth believes that women and health care providers need complete and accurate information about all medications. It is critical for the FDA to fully address the issues raised in Wyeth's petition regarding bio-identical hormone replacement therapies for consumers, health care providers, and the compounding industry so that everyone can be fully informed about the risks associated with these products.
On April 4, 2006, Wyeth filed a supplement to its petition, responding to misunderstandings and misstatements about its petition in comments filed with the FDA.
About Hormone Therapy
Hormone therapy isn't right for all women. It doesn't prevent heart disease and may increase your chance of heart attack, breast cancer, stroke, blood clots, or dementia. If you have a uterus, estrogen increases the risk of uterine cancer. Adding progestin greatly reduces this risk. The use of estrogens and progestins should be reevaluated regularly with your healthcare provider and should be taken for the shortest time based on your individual goals and risks. If you're not having menopausal symptoms, non-estrogen treatments should be considered before starting estrogen therapy to prevent bone loss.
About Wyeth
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, 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.
WyethCONTACT: Media Contacts: Candace Steele, Wyeth Pharmaceuticals,+1-484-865-5428, or Doug Petkus, Wyeth, +1-973-660-5218, or Investors:Justin Victoria, Wyeth, +1-973-660-5340
Web site: http://www.wyeth.com//
