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August 30, 2007

Some Prescribed Drugs Aren’t FDA Approved

Most everyone assumes if a doctor prescribes a drug or it's available through a pharmacy, then it's been approved by the Food and Drug Administration. That statement however, is not true. Hormone replacement therapy is a common treatment for women going through menopause. In the past couple of years studies have found the drugs can have dangerous side effects. One study released found women taking the drugs had twice the risk of breast cancer. Even though it's been prescribed to thousands of women, the drug Estratest has never been approved by the FDA. Estratest is a widely prescribed combination of synthetic estrogen and testosterone to treat the symptoms of menopause. One woman experienced an increase in facial acne and hair growth. It was the testosterone that seemingly caused it. Estratest has never been approved by the FDA and by law all drugs are required to get FDA approval before they are sold. Since Estratest has been on the market since 1964, most people assume it's been approved. The maker of Estratest applied for approval in 1979, but the FDA turned them down. The company tried again in 1981. Twenty-six years later and there is still no approval. The company doesn't hide the fact. Its literature clearly states, "This product has not obtained FDA pre-market approval." A federal appeals court in Atlanta said it was baffled and wrote, "It is incomprehensible that Estratest has been allowed on the market without approval for 35 years." They added, "There can be no good excuse for allowing a company to violate the law for 35 years."

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