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【medical-news】FDA叫停治疗绝经期症状的生物类激
The Food and Drug Administration ordered seven pharmacies Wednesday to stop making "false and misleading" claims about custom-made "bioidentical" hormones for menopausal symptoms.
Though seven pharmacies were targeted for misleading marketing by the agency, they are only a tiny fraction of the estimated thousands of pharmacies that custom-mix so-called bioidentical hormones. Pharmacies are allowed to "compound" their own drugs if they have a doctor's prescription for a product not otherwise commercially available.
Women began turning to such custom-made treatments in larger numbers after a landmark study in 2002 that found traditional brand-name drugs produced by pharmaceutical companies may raise the risk of heart attack, breast cancer or stroke.
The FDA took action against the pharmacies, which often market their compounds online, for three main reasons. It said the businesses claimed their mixtures could prevent or treat illnesses such as Alzheimer's disease, stroke and cancer; claimed the mixtures were superior to approved commercial drugs; and used the hormone estriol, a weak estrogen that isn't FDA-approved.
Makers of bioidentical hormones say their custom-made compounds are tailored to a woman's individual needs, based on the contents of her saliva. Actress Suzanne Somers has promoted them energetically.
But Kathleen Uhl, director of the agency's Office of Women's Health, says saliva tests aren't a reliable way to balance out hormones, which fluctuate by the hour. Tailor-made hormone therapies pose the same risks as commercially prepared hormone therapies, Uhl says.
Wyeth, which makes two of the most commonly used brand-name hormone therapies, Prempro and Premarin, asked the FDA in 2005 to take action against compounders making similar products.
Compounding pharmacies protested, and the FDA says it received nearly 70,000 comments from both sides.
Terry Scarborough, an attorney for one of the pharmacies that received a warning letter, notes that a group of pharmacists has sued the federal government, arguing that the FDA doesn't have authority to regulate compounded drugs.
"Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate," says L.D. King, executive director of the International Academy of Compounding Pharmacists. "This is a decision that should be left to doctors."
Wulf Utian, executive director of the North American Menopause Society, praised the FDA's action. He discourages women from turning to compounded hormones.
"If there is a reason to be on hormone therapy, there are more than enough approved products out there," Utian says.
http://www.usatoday.com/news/health/2008-01-09-bioidentical-hormones-fda_N.htm 国际绝经协会的最新激素治疗指南--协和医院妇产科—孙爱军医生个人网站
http://www.***.net/user1/371/archives/2007/12054.html
屏蔽了，大家自己google下吧 本人已申请翻译，48小时内上传译文 FDA cracks down on makers of 'bioidentical' hormones
FDA处罚生物类激素制造商
The Food and Drug Administration ordered seven pharmacies Wednesday to stop making "false and misleading" claims about custom-made "bioidentical" hormones for menopausal symptoms.
美国食品药品管理局在星期三叫停7家药房针对绝经期症状量身定做生物类激素的宣传，认为那是错误和误导性的。
Though seven pharmacies were targeted for misleading marketing by the agency, they are only a tiny fraction of the estimated thousands of pharmacies that custom-mix so-called bioidentical hormones. Pharmacies are allowed to "compound" their own drugs if they have a doctor's prescription for a product not otherwise commercially available.
尽管这7家药房以误导市场消费被（FDA）处罚，他们只是生产备受公众推崇的生物类激素的数千药房中的很小一部分。药房在有医生处方的情况下可以制备配方制剂，而不是为了商业便利。
Women began turning to such custom-made treatments in larger numbers after a landmark study in 2002 that found traditional brand-name drugs produced by pharmaceutical companies may raise the risk of heart attack, breast cancer or stroke.
在2002年的一项研究结果中，发现传统的制药公司制造的商标药可能会增加心脏病发作，乳腺癌或中风的发生率，这使得越来越多的妇女倾向与这种量身定做的治疗方案。
The FDA took action against the pharmacies, which often market their compounds online, for three main reasons. It said the businesses claimed their mixtures could prevent or treat illnesses such as Alzheimer's disease, stroke and cancer; claimed the mixtures were superior to approved commercial drugs; and used the hormone estriol, a weak estrogen that isn't FDA-approved.
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作者:admin@医学,生命科学 2011-08-29 17:14
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