| #ffffff;" /> | | | | health care providers the drugs' risks and whether |
| In a blow to certain drug makers, the FDA has sent | | | | they're getting effective treatment." (see for more info |
| letters warning seven pharmacy operations that the | | | | on the FDA’s stance on BIO HRT.) |
| claims they make about the safety and effectiveness | | | | So, what does this mean to your menopause |
| of their so-called "bio-identical hormone replacement | | | | symptoms treatment options? The most important |
| therapy," or "BHRT" products are unsupported by | | | | thing to consider is that no drug product containing |
| medical evidence, and are considered false and | | | | estriol has been approved by FDA and the safety and |
| misleading by the agency. According to the FDA, they | | | | effectiveness of estriol is unknown. There are, |
| are concerned that unfounded claims like these | | | | however, many natural and alternative treatments for |
| mislead women and health care professionals. | | | | menopausal symptoms that ARE proven safe and |
| Bioidentical hormones are custom-mixed formulas | | | | effective. |
| containing various hormones that are designed to be | | | | Herbal menopause treatment, for example is a natural |
| chemically identical to those naturally made by your | | | | and increasingly popular alternative, since it is gentle |
| body. These prescription and over-the-counter | | | | and works in harmony with the woman’s body. |
| products are marketed as being superior to other | | | | However, it is important that a woman taking herbs |
| FDA-approved HRT regimens, and are tailored to a | | | | should tell her doctor because just as with prescription |
| woman's individual hormone needs, typically determined | | | | drugs, herbs can also present possible interactions with |
| through saliva hormone testing. Manufacturers claim | | | | other drugs or herbs, thus causing side effects. |
| that bioidentical hormones are even safer than | | | | Additionally, there are a number of foods and herbs |
| standard, FDA-approved hormone therapy. | | | | that include natural plant estrogens, known as |
| The FDA states that the pharmacy operations in | | | | phytoestrogens, which are hormone regulators of |
| question improperly claim that their drugs, which contain | | | | natural progesterone and estrogen. These too can be |
| hormones such as estrogen, progesterone, and estriol | | | | very beneficial in the treatment of menopausal |
| (which is not a component of an FDA-approved drug | | | | symptoms. |
| and has not been proven safe and effective for any | | | | “Menopause Formula” is herbal-based |
| use) are superior to FDA-approved menopausal | | | | and an all-natural nutritional supplement that contains |
| hormone therapy drugs and prevent or treat serious | | | | phytoestrogens. Soy products also contain |
| diseases, including Alzheimer's disease, stroke, and | | | | phytoestrogens and may be helpful in reducing hot |
| various forms of cancer. | | | | flashes and osteoporosis, along with treatment of |
| The FDA is concerned that the claims for safety, | | | | vaginal dryness. It is important to remember that the |
| effectiveness, and superiority that these pharmacy | | | | effects of soy protein, which is found in whole foods, |
| operations are making mislead patients, doctors and | | | | soy protein isolates, and products containing isoflavone |
| other health care professionals. Compounded drugs | | | | isolates, may not all be the same. Some other |
| are not reviewed by the FDA for safety and | | | | alternatives for herbal menopause treatment include |
| effectiveness, and the FDA encourages patients to | | | | black cohosh, which relieves menopausal symptoms |
| use FDA-approved drugs whenever possible. The | | | | such as hot flashes and night sweats, and chaste tree, |
| warning letters issues by the FDA state that the | | | | which has a calming and soothing effect along with |
| pharmacy operations violate federal law by making | | | | noted relief of headaches and tenderness of the |
| false and misleading claims about their hormone | | | | breasts. |
| therapy drugs. | | | | Wild yam is yet another option to herbal menopause |
| "We want to assure that Americans receive accurate | | | | treatment, containing compounds that are similar to |
| information about the risks and benefits of drug | | | | progesterone and very helpful in relaxing muscle |
| therapies," said Dr. Janet Woodcock, FDA's chief | | | | spasms while also reducing inflammation associated |
| medical officer and acting director of the agency's | | | | with menopause-related symptoms. Last but not least |
| Center for Drug Evaluation and Research. "In addition | | | | is rosemary. This particular herb is excellent for treating |
| to today's regulatory action, FDA is publishing an | | | | headaches and circulatory problems, while also fighting |
| informational article for women on its consumer health | | | | free radicals in the body and relaxing the stomach for |
| information web page that provides the facts to make | | | | better digestion. These and other natural alternatives |
| informed decisions about these unapproved therapies. | | | | have not been scientifically proven but have been |
| Women taking these drugs should discuss with their | | | | used by many healthy women for years. |