FDA Takes Action Against Compounded HRT Drugs - What It Means To You

In a blow to certain drug makers, the FDA has 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. According to the FDA, they are concerned that unfounded claims like these mislead women and health care professionals.

Bioidentical hormones are custom-mixed formulas containing various hormones that are designed to be chemically identical to those naturally made by your body. These prescription and over-the-counter products are marketed as being superior to other FDA-approved HRT regimens, and are tailored to a woman's individual hormone needs, typically determined through saliva hormone testing. Manufacturers claim that bioidentical hormones are even safer than standard, FDA-approved hormone therapy.

The FDA states that the pharmacy operations in question 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 operations are making mislead patients, doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and the FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters issues by the FDA 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." (see http://www.fda.gov/consumer/updates/bioidenticals010908.html for more info on the FDA's stance on BIO HRT.)

So, what does this mean to your menopause symptoms treatment options? The most important thing to consider is that no drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. There are, however, many natural and alternative treatments for menopausal symptoms that ARE proven safe and effective.

Herbal menopause treatment, for example is a natural and increasingly popular alternative, since it is gentle and works in harmony with the woman's body. However, it is important that a woman taking herbs should tell her doctor because just as with prescription drugs, herbs can also present possible interactions with other drugs or herbs, thus causing side effects. Additionally, there are a number of foods and herbs that include natural plant estrogens, known as phytoestrogens, which are hormone regulators of natural progesterone and estrogen. These too can be very beneficial in the treatment of menopausal symptoms.

"Menopause Formula" is herbal-based and an all-natural nutritional supplement that contains phytoestrogens. Soy products also contain phytoestrogens and may be helpful in reducing hot flashes and osteoporosis, along with treatment of vaginal dryness. It is important to remember that the effects of soy protein, which is found in whole foods, soy protein isolates, and products containing isoflavone isolates, may not all be the same. Some other alternatives for herbal menopause treatment include black cohosh, which relieves menopausal symptoms such as hot flashes and night sweats, and chaste tree, which has a calming and soothing effect along with noted relief of headaches and tenderness of the breasts.

Wild yam is yet another option to herbal menopause treatment, containing compounds that are similar to progesterone and very helpful in relaxing muscle spasms while also reducing inflammation associated with menopause-related symptoms. Last but not least is rosemary. This particular herb is excellent for treating headaches and circulatory problems, while also fighting free radicals in the body and relaxing the stomach for better digestion. These and other natural alternatives have not been scientifically proven but have been used by many healthy women for years. Therefore, for the woman tired of taking prescription medication or just dealing with the symptoms of menopause, these and other natural remedies are highly recommended.

Dawn M. Olsen is an Advocate for Better Women's Health through Education. Visit Menopause A to Z if you need menopause support, or just need to find out more about how to approach and relieve your menopause symptoms.

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