The US Food and Drug Administration (FDA) informed the public of new safety information for drugs called 5-alpha reductase inhibitors (5-ARIs). Men who take these drugs may have an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). The Warnings and Precautions section of the labels for all FDA-approved 5-ARIs has been revised to include information about this risk.
Q1. What data are available on this safety issue?
A. The data that formed the basis for these labeling changes were based on two large, randomized controlled studies assessing the ability of 5-ARIs to reduce the rate of diagnosis of prostate cancer over a period of 7 years (Proscar) and 4 years (Avodart), respectively, in men at least 50 years of age.
The Proscar trial evaluated the use of 5 mg doses of finasteride (Proscar) versus a placebo (sugar pill), and the Avodart trial evaluated the use of 0.5 mg doses of dutasteride (Avodart) versus a placebo, for the reduction of prostate cancer risk.
The trials demonstrated an overall reduction in prostate cancer diagnoses with finasteride and dutasteride treatment. This overall reduction was due to a decreased incidence of lower risk forms of prostate cancer. However, both the finasteride trial and the dutasteride trial showed an increased risk of high-grade prostate cancer.
It is important to note that neither trial evaluated 1 mg doses of finasteride (Propecia), used to treat male pattern hair loss.
Q2. Why is the labeling of Propecia being changed when this drug was not included in either study?
A. The labeling of Propecia is being changed to reflect the possibility of an increased risk of high-grade prostate cancer because Propecia contains 1 mg of finasteride. Although this is lower than the amount of finasteride in Proscar (5 mg), the active ingredient is the same.
It is still important to note that the applicability of the Avodart and Proscar studies to Propecia is currently unknown. The outcomes of both studies have been added to the Propecia labeling out of caution.
Men taking Propecia for hair loss should talk to their healthcare professional about the risks and benefits of this drug to determine the most appropriate treatment.
Q3. Does FDA believe the benefits of 5-alpha reductase inhibitors (5-ARIs) still outweigh their risks?
A. Yes. FDA believes that 5-ARIs remain safe and effective for their approved indications. Proscar and Avodart have been effective in controlling symptoms of benign prostatic hyperplasia (BPH), as well as in reducing the risks of acute urinary retention and the need for surgical intervention related to BPH.
Healthcare professionals and patients are still encouraged to discuss the risks and benefits of 5-ARIs when deciding the best treatment for their disease.
FDA will continue its risk/benefit assessment of using 5-ARIs for the treatment for male pattern hair loss and will update the public when additional information is available.
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