Hormone Therapy Linked to Abnormal Test Results
February 26, 2008
Combined hormone replacement therapy may affect the effectiveness and accuracy of breast screening mammograms and tissue sample tests, called biopsies, study results show.
Lead researcher Dr Rowan Chlebowski, from Harbor-University of
Dr Chlebowski and team analysed data from a study of more than 16,600 postmenopausal women who took either a combination of oestrogen and progesterone or a dummy hormonal treatment for around 5 years.
In total, 199 of the women taking combined hormone therapy and 150 of those taking the dummy treatment developed breast cancer over the course of the study.
Abnormal mammogram results were significantly more common among women taking combined hormone treatment (35%) than among those taking the dummy treatment (23%). Indeed, women taking combined hormone therapy had a 4% greater risk of having a mammogram with abnormalities after 1 year and an 11% greater risk after 5 years compared with those taking the dummy treatment.
Learn More: Archives of Internal Medicine
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FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
January 10, 2008
The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called “bio-identical hormone replacement therapy,” or “BHRT” products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.
The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer’s disease, stroke, and various forms of cancer.
FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
“We want to assure that Americans receive accurate information about the risks and benefits of drug therapies,” said Dr. Janet Woodcock, FDA’s chief medical officer and acting director of the agency’s Center for Drug Evaluation and Research. “In addition to today’s regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies. Women taking these drugs should discuss with their health care providers the drugs’ risks and whether they’re getting effective treatment.”
The pharmacy operations receiving warning letters use the terms “bio-identical hormone replacement therapy” and “BHRT” to imply that their drugs are natural or identical to the hormones made by the body. FDA regards this use of “bio-identical” as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis.
The pharmacy operations also make unsupported claims that their drugs are better than FDA-approved menopausal hormone therapy drugs and can be used to prevent and treat serious diseases such as Alzheimer’s disease, stroke, and various forms of cancer.
The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. No drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown.
Firms that do not properly address violations identified in warning letters risk further enforcement, including injunctions that prevent additional violations, and seizure of violative drugs.
FDA’s action today does not target pharmacists who practice traditional pharmacy compounding and who do not make false or misleading claims about compounded products. Traditional pharmacy compounding typically involves preparation of a drug for an individual patient by a pharmacist in response to a valid prescription from a licensed practitioner. This compounding follows a practitioner’s decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs.
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