Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
The U.S. Food and Drug Administration (FDA) today stated that there is no scientific basis for the effectiveness and safety of the so-called "bioidentical hormone" products currently on the market, which claim to alleviate menopausal symptoms and combat aging in women. The FDA also issued warning letters to seven companies, accusing them of misleading consumers and healthcare professionals, in violation of federal law.
Hormone replacement therapy is used by the medical community to improve menopausal symptoms in women and is also claimed to have anti-aging effects, potentially extending lifespan. The so-called "bioidentical hormone replacement therapy" (BHRT) has recently been promoted by some U.S. film and television celebrities, appearing not only in the anti-aging market but also being sold online.
Some studies have suggested that traditional hormone replacement drugs may increase the risk of heart disease, breast cancer, and stroke. However, promoters of "bioidentical hormones" claim that their drugs contain hormones such as estrogen, progesterone, and estriol, which are better than FDA-approved menopausal hormone therapy drugs.
They claim that these compounded hormones are chemically processed to match the structure of human hormones, making them easily absorbed and fully utilized by human cells and tissues, and can prevent or treat some major diseases, such as Alzheimer's disease, stroke, and cancer.
However, the FDA today pointed out that these companies have made improper claims, and the estriol contained in these drugs is not an FDA-approved drug component and has not been proven to be effective or safe.
The FDA also stated that the use of the term "bioidentical" as a marketing term by these companies has no scientific basis. They expressed concern that the companies' claims are misleading patients, doctors, and healthcare professionals, and urged patients to use FDA-approved drugs.
However, the International Academy of Compounding Pharmacists today issued a statement saying that the FDA's policy prevents many women from using compounded hormones. They criticized that Wyeth, a major supplier of hormone replacement drugs, had previously requested the FDA to impose such regulations.
The FDA emphasized in a statement that this action is not targeting pharmacists who compound drugs according to the individual needs of patients, nor those who do not make false or misleading claims about compounded drugs.
Given the potential side effects of traditional hormone therapy, experts also recommend that women who need hormone replacement therapy to alleviate menopausal symptoms should take the lowest possible dose of medication for the shortest possible time.The seven companies that received warning letters from the FDA are: Panorama Compounding Pharmacy of Lake Balboa, California; Saint John's Medical Plaza Pharmacy of Santa Monica, California; Murray Avenue Apothecary of Pittsburgh, Pennsylvania; Village Compounding Pharmacy of Houston, Texas; Pharmacy Compounding Specialties of Dallas, Texas; Reed's Compounding Pharmacy of Tucson, Arizona; and Pacifica Pharmacy of Torrance, California. 970109
Source: http://www. udn. com/ 2008/ 1/ 10/ NEWS/ HEALTH/ HEA1/ 4174641. shtml
Safety Concerns with Seven Compound Hormones
Hormone replacement therapy is used by the medical community to improve menopausal symptoms in women and is also claimed to have anti-aging effects, potentially extending lifespan. The so-called "bioidentical hormone replacement therapy" (BHRT) has recently been promoted by some U.S. film and television celebrities, appearing not only in the anti-aging market but also being sold online.
Some studies have suggested that traditional hormone replacement drugs may increase the risk of heart disease, breast cancer, and stroke. However, promoters of "bioidentical hormones" claim that their drugs contain hormones such as estrogen, progesterone, and estriol, which are better than FDA-approved menopausal hormone therapy drugs.
They claim that these compounded hormones are chemically processed to match the structure of human hormones, making them easily absorbed and fully utilized by human cells and tissues, and can prevent or treat some major diseases, such as Alzheimer's disease, stroke, and cancer.
However, the FDA today pointed out that these companies have made improper claims, and the estriol contained in these drugs is not an FDA-approved drug component and has not been proven to be effective or safe.
The FDA also stated that the use of the term "bioidentical" as a marketing term by these companies has no scientific basis. They expressed concern that the companies' claims are misleading patients, doctors, and healthcare professionals, and urged patients to use FDA-approved drugs.
However, the International Academy of Compounding Pharmacists today issued a statement saying that the FDA's policy prevents many women from using compounded hormones. They criticized that Wyeth, a major supplier of hormone replacement drugs, had previously requested the FDA to impose such regulations.
The FDA emphasized in a statement that this action is not targeting pharmacists who compound drugs according to the individual needs of patients, nor those who do not make false or misleading claims about compounded drugs.
Given the potential side effects of traditional hormone therapy, experts also recommend that women who need hormone replacement therapy to alleviate menopausal symptoms should take the lowest possible dose of medication for the shortest possible time.The seven companies that received warning letters from the FDA are: Panorama Compounding Pharmacy of Lake Balboa, California; Saint John's Medical Plaza Pharmacy of Santa Monica, California; Murray Avenue Apothecary of Pittsburgh, Pennsylvania; Village Compounding Pharmacy of Houston, Texas; Pharmacy Compounding Specialties of Dallas, Texas; Reed's Compounding Pharmacy of Tucson, Arizona; and Pacifica Pharmacy of Torrance, California. 970109
Source: http://www. udn. com/ 2008/ 1/ 10/ NEWS/ HEALTH/ HEA1/ 4174641. shtml