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. FDA's current view on human drug compounding is addressed in its compounding Compliance Policy Guide, available at http://www.fda.gov/cder/pharmcomp/default.htm.

FDA also responded today to a citizen petition from Wyeth, Madison, NJ, asking FDA to take 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. 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. 

For more information, see a consumer article called Bio-Identicals: Sorting Myths from Facts http://www.fda.gov/consumer/updates/bioidenticals010908.html. 

Warning Letters and Q and A's are available at http://www.fda.gov/cder/pharmcomp/default.htm.

Dr. Erika Schwartz: "Estriol is a human hormone produced by the human body. It is one of the three estrogen molecules and the most abundant during pregnancy. Women who cannot tolerate estradiol may use estriol. Like many commonly prescribed drugs (e.g. quinine, Phenobarbital, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP). When Congress passed the FDA Modernization Act in 1997, it clearly indicated that drugs with a USP monograph could be compounded."

Suzanne Somers: "I have learned that natural bioidentical hormones are the secret to handling this passage of life (not the synthetic hormones that only slap a Band-Aid on your menopausal symptoms and have garnered so much controversy in medical studies, and certainly not black cohosh and yams). "

Karen Giblin: "Women need to recognize that bio-identicals are not regulated, not proven safe or effective and do have risks associated with them. “I truly have never figured out why women consider bio-identicals as the new hope in the bottle,” says Karen Giblin, president of Prime Plus/Red Hot Mamas. “The FDA's release should promote using these problems with caution.” It should be a woman's choice to put whatever she chooses in her own body, but she must fully understand these products are not scientifically proven to be safe or even work at all. "

Marcelle Pick: "First," says Pick, "it is important that women understand the message: the FDA has not outlawed the use of bio-identical HRT. Second, it's the job of a reputable compounding lab to prepare a product that has the same molecular structure as the hormones your body produces naturally --- the word 'bio-identical' in this sense means 'identical to life.' If a woman is lacking the hormones she needs to feel balanced, bHRT, as compared to synthetics, allows the body to metabolize the hormones in much the same way as it was designed to do naturally. This is the key to minimizing side effects."

Christiane Northrup: "There seems to be a lot of confusion around the definition of "natural" versus "bioidentical versus "synthetic" hormones. One thing to remember when making this distinction is that "bioidentical" refers to the shape of the molecule itself rather than the source of the hormone. By this, I mean that hormones can be marketed as "natural" or "plant-based," yet not come near to being "bioidentical" to native human female hormones or performing as such in the body. Examples of this are the numerous proprietary HRT options being marketed as "plant-based" and "natural," as well as purely yam-based creams."

The Endocrine Society's Position Statement on bioidentical hormones published October 2006 -- and it's officially endorsed by NAMS.

NAMS MenoNote® on bioidentical hormones

BHRT At Risk: Take Action to Save BHRT!

Last week FDA made a horrible decision—choosing Wyeth’s wealth over patient health.  FDA agreed to support Wyeth in their campaign to end compounded hormone replacement therapy—specifically by starting a crackdown on the use of estriol which FDA claims is illegal.

We are calling on you to GET INVOLVED AND FIGHT BACK!

We are working to engage Members of Congress to call on FDA to reverse its decision. We need your help to contact your Representatives and Senators in Congress and encourage them to stand up for the rights of women. 

It’s easy and effective. Simply click here to send a letter to each of your Representatives and Senators in Congress. There, you will find a sample letter that you can tailor and send to your elected officials, the Small Business Administration and FDA with one click of the mouse. 

Once you’ve sent your letters, you can also call your members of Congress and tell them why FDA’s action supporting Wyeth is wrong. Use IACP’s easy-to-use call alert system. Talking points and phone numbers for your members of Congress are provided within the call alert system. 

The time is now for us to take action to save BHRT—especially the use of estriol. We need your help to ensure that the FDA and Wyeth are not allowed to rob patients of the treatments they are prescribed to enjoy happier, healthier lives.

Click here to take action now!