Think Bio-Identicals are Safer? Think Again
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.
Confused about bio-identical hormone therapy? View the FDA's updated consumer health sheet: "Bio-Identicals: Sorting Myths from Facts"
To chat with the author or discuss this article or your symptoms, log onto our bulletin boards . References
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.
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The 2007 Hot List of Top 10 Books to Get You Through Menopause
Just the other day I was in a fairly large bookstore perusing the “Women's Health” section to see what was new on the shelves this holiday season. I noticed there were quite a number of recently published books on menopause. Many were titles I haven't heard of before. Others, I quickly recognized as the staples I always refer back to when I have a question.
Every year, I reassess my bookshelf to see what has made the cut and what hasn't. This year's “Hot List of Top 10 Books to Get You Through Menopause” includes many favorites that have reappeared through the years as well as new ones I have added to the list of must-reads. There's no reason to be overwhelmed at the bookstore anymore. Yes, there are tons of books to choose from to help you through menopause but which ones are THE best? Here they are! Happy shopping!!
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 Is It Hot in Here? Or Is It Me?: The Complete Guide to Menopause, 2006, by: Barbara Kantrowitz and Kelly Wingert: Workman Publishing. Menopausal woman have other health concerns that are sometimes overlooked. This book offers information on such topics like the “danger signs in pigmented lesions of the skin”, as well as other changes that occur that may affect women's health and well-being. The authors provide a broad spectrum of health information which is certainly very useful. In a question and answer format, the authors try to satisfy the needs of those with individualized medical problems.
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 Hot Flashes, Hormones & Your Health, 2007, by: JoAnn E. Manson, M.D. and Shari S. Bassuk: McGraw- Hill. If you are considering hormone therapy, read this book. It will guide you through the often confusing process of weighing the benefits and risks of the different types of hormone therapy. The authors clearly explain the most recent findings from the Women's Health Initiative and Nurse's Health Study. The truth about bioidentical hormones is revealed along with alternative options to managing your menopause without the use of hormone therapy.
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 A Woman's Guide to Menopause & Perimenopause, 2005, by: Mary Jane Minkin. This book is always by my side (or close by). Co-authored by Red Hot Mamas health advisor and national medical expert, Dr. Mary Jane Minkin, this book will tell you everything you need to know about menopause and more. Information is presented in an easy to read, well-organized format. It is essential reading for anyone looking for answers to the many different aspects of women's health during menopause and beyond.
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The Wisdom of Menopause, 2006, by: Christiane Northrup, M.D.: Bantam Books. After reading this book, you will want to hug Christiane Northrup. She is the brain child behind “feminine intelligence”. She really delves into the mind/body connection that revolutionized her first book, Women's Bodies Women's Wisdom. She brings you through her personal journey as she reveals the secrets behind making the most of these often tumultuous years at menopause.
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The Wisdom of Menopause Journal, 2007, by: Christiane Northrup, M.D.,: Hay House Inc. Keeping a journal at menopause is a great way to be in touch with yourself and monitor the physical and emotional changes you are going through at this time in your life. By logging daily or weekly, you or your doctor may find patterns that are triggering certain menopause symptoms (i.e., hot flashes, sex challenges, etc.). After looking back at your entries, it will be clearer which interventions or therapies work (and most importantly don't work) for you.
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 Your Perfectly Pampered Menopause, 2005, by: Colette Bouchez, Broadway Books. There is so much seriousness surrounding menopause, this book offers some good comic relief to the sometimes overly-serious subject. Take Chapter 9 for example, “Your Brain On Menopause…Or, Why you Cry When the Bakery is Out of Rye Bread”. It truly is a breath of fresh air to read hilarious stories you can relate to. Don't be fooled by the fluffy title or the foofy cover. This book is fil led with great, up-to-date information for living well and coping with the sometimes dreary symptoms of menopause.
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 Our Bodies, Ourselves: Menopause, 2006, by: The Boston Women's Health Book Collective, Simon & Schuster. Wow! This book has a ton of information! This is a wonderful source of comprehensive information not only for menopause but for women's health in general. What this book touches on that most other menopause books leave out is the social, cultural and political aspects of menopause. This book succeeds in many ways including empowering women to make their own healthcare decisions.
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 Menopause for Dummies, 2 nd Edition, 2006, by: Marcia L. Jones, Ph.D., Theresa Eichenwald, M.D., Nancy W. Wall; Wiley Publishing. This book continues to be on our favorites list year after year. Like all “Dummies” books, it presents information in an easy to read format that is not too text-heavy. The icons make it easy to locate specific information (i.e. tips, remember, see an expert, etc). It tackles all the important aspects of menopause and offers sound advice from top experts with some humor, which we can all appreciate.
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 The Essential Guide to Hysterectomy, 2004, by: Lauren F. Streicher, M. Evans and Company. Looking for fast information about hysterectomy? Look no further. This book has the answers to all of your questions. There are many physical and emotional aspects of having a hysterectomy that this book covers in detail. Educate yourself fully before and after your hysterectomy and your recovery will be much smoother. Share the information with your doctor and even bring the “walk-through” to the day of surgery.
 Fit and Sexy for Life, 2007, by: Kathy Kaehler, Broadway Books. Let's face it. A whole slew of physical and emotional changes are associated with growing older. In her new book, Kathy Kaehler encourages her readers to meet these challenges head on. “…I won't be pausing for menopause—and neither should you.” This book sends a strong message to perimenopausal and menopausal women—bring them on!
We are in no way financially tied or compensated by any of these authors or publishers. We simply think they're the most helpful and medically sound ones currently available. top
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