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ASRM BULLETIN
Volume 10, Number 1
January 10, 2008
FDA Sends Warning Letters to Pharmacies;
Claims about “Bio-Identical HRT” Are False and Misleading
Yesterday, the U.S. Food and Drug Administration (FDA) announced that it had 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.
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.
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. The warning letters are available to the public at http://www.fda.gov/cder/pharmcomp/default.htm.
FDA also responded yesterday to a citizen petition from Wyeth, Madison, NJ, requesting regulatory action against compounding pharmacy operations that produce compounded "BHRT" drugs. Other stakeholders, including health care providers and consumer groups, have also raised concerns about "BHRT" drugs.
All patients who use compounded hormone therapy drugs should discuss menopausal hormone therapy options with their health care provider to determine if compounded drugs are the best option for their specific medical needs. For more information, see the consumer article, “Bio-Identicals: Sorting Myths from Facts” at http://www.fda.gov/consumer/updates/bioidenticals010908.html.
If patients or practitioners encounter problems with compounded hormone therapy drugs, they are encouraged to file a MedWatch report with the FDA at
www.fda.gov/medwatch
or by phone at 1-800-FDA-1088.
The ASRM Bulletin is published by ASRM's Office of Public Affairs to inform Society members of important recent developments. Republication or any other use of the contents of the Bulletin without permission is prohibited. To request permission to quote or excerpt material from the Bulletin, contact Sean Tipton at
stipton@asrm-dc.org.
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