Think Bioidenticals are Safer? Think Again

By: Red Hot Mamas

Published: July 13, 2010

When we really struggle with something, it is easy to gain a false-hope in a quick-fix that is usually too good to be true. Many women, including myself, struggle with the difficult symptoms of menopause and just want to feel better safely and quickly. When a therapy promises, a natural, safer alternative to dangerous prescription drugs, it sounds like the best route to feeling better. But, is it too good to be true?

According to a recent statement from the U.S. Food and Drug Administration, hormones prepared by compounding pharmacists are no safer than hormones prepared by traditional pharmacists. While bio-identical hormone therapy is found to be very effective for some women, there is no evidence that proves it doesn’t have the same associated side effects and risks as FDA-approved drugs. So saying it’s “safer” is misleading.

On January 9, 2008, the FDA boldly announced they are taking action against several compounding pharmacies who promote these false claims. Many pharmacy compounders use the term bio-identical to imply that their drugs are natural or natural to hormones made by the body, said Deborah M. Autor, director of the FDA’s Office of Compliance in the Center for Drug Evaluation and Research. There is no creditable scientific support for this claim.

What about those women who can’t tolerate commercial drug products for one reason or another? In that case, they need another option. Quite often, this is where the compounding pharmacy comes into play. Doses and mixtures of products that are not commercially available can be individualized. It is an important resource for many women and when used appropriately, the FDA considers it to be a valuable service. But, a problem starts when some pharmacies began marketing bio-identical drug products with no scientific evidence to back up their statements. And, this is precisely why the FDA decided to recently chime in.

The FDA actually states BHRT’ is a marketing term not recognized by the FDA. Pharmacies who promote bio-identical hormones as natural or identical to the hormones made by the body are being warned by the FDA because the terms are unsupported by medical evidence and considered false and misleading.

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.”

The Red Hot Mamas support the FDA’s decision along with the North American Menopause Society, The Endocrine Society and the American College of Obstetricians and Gynecologists to finally take a stance against the false and misleading advertising claiming that compounded hormones are better and safer than commercial drugs. Women and healthcare providers deserve to be armed with clinically proven, reliable information on all hormone therapy that is available for menopause.

So what can we believe about bioidentical hormone therapy? On Wednesday, the FDA released an updated consumer health sheet, Bio-Identicals: Sorting Myths from Facts. This sheet answered all my lingering questions about the regulation of bioidenticals. Like all therapies and medications, talk to your doctor and pharmacist to determine if compounding drugs are the best option for your individual medical needs.


FDA News (January 9, 2008). “FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs”. Press Release. Retrieved on 2008-01-10.

Parker-Pope, Tara (January 9, 2008). “A Hormone Is a Hormone, F.D.A. Says”. Well Tara Parker-Pope on Health. Retrieved on 2008-01-10.

Reinberg, Steven (January 10, 2008). “FDA Warns Against Bio-Identical Hormone Therapy”. HealthDay. Retrieved on 2008-01-10.

Schmid, Randolph, (January 9, 2008). “FDA Cracks Down on Custom-Made Hormones”. Associated Press. Retrieved on 2008-01-10.

Wilde Matthews, Anna and Rubenstein, Sarah (January 10, 2008). “FDA Warns Pharmacies On Hormone Claims”. The Wall Street Journal Online. Retrieved on 2008-01-10.