Private MD News

FDA denies approval of prostate treatment

Category: Prostate

Drugs that could potentially prevent the development of prostate cancer in men who have slightly elevated PSA test scores were recently struck down by the Food and Drug Administration over concerns that they may actually increase the risk of high-risk cancer.

Finasteride and dutasteride are currently already available for the treatment of enlarged prostate glands. However, their manufacturers were seeking approval that would have allowed them to begin marketing the drugs as a preventative measure against low-grade tumors, according to MedPage Today.

However, the FDA rejected the proposal after evidence emerged that they may actually increase the chances of high-risk prostate cancer in men who received elevated PSA test scores. Experts said that the drug met a non-need, as low-risk prostate cancer by nature rarely develops into a deadly condition.

"If you're going to give normally healthy people a drug, there needs to be no side effects," Patrick Walsh, a urologist who has studied the drug and who was brought in to consult on the matter by the FDA, told the news source.

Ultimately, the FDA said that the potential risks far outweighed the limited benefits from giving these drugs to men with elevated PSA test scores, according to Reuters.