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FDA panel says no to prostate cancer preventives

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The US FDA's Oncologic Drugs Advisory Committee has overwhelmingly voted against the use of two drugs to prevent prostate cancer.

The drugs, 5-alpha reductase inhibitors dutasteride (Avodart) and finasteride (Proscar), are currently FDA approved in the treatment of an enlarged prostate, also known as benign prostatic hypertrophy.

Each drug's manufacturers were seeking additional indications for their drugs. However, the FDA panel was clear in stating that these drugs should not be given as preventive medicine to men who do not have prostate cancer or who only have an elevated PSA but no indication of cancer.

The reason given was because recent clinical trials had demonstrated a link between the use of the drugs in a preventive setting and an increased incidence of high-grade prostate cancer tumors.

While the FDA is under no obligation to follow the recommendation of this panel, it typically does.


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