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Pharmacy Focus

FDA Alerts Healthcare Professionals About Bio-Identical Hormone Replacement Therapy Products

The FDA has informed healthcare professionals and patients that it has sent letters warning seven pharmacy companies 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.

The pharmacy companies 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. The FDA is concerned that the claims for safety, effectiveness and superiority that these pharmacy companies are making mislead patients, as well as doctors and other healthcare professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness.

Patients who use compounded hormone therapy drugs should discuss menopausal hormone therapy options with their healthcare provider to determine if compounded drugs are the best option for their specific medical needs.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA news release regarding this issue, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Menopause