FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
Featured In: Regulatory News
By Federal Drug Administration
Thursday, June 9, 2024
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FDA Drug Safety Communication: 5-alpha
reductase inhibitors (5-ARIs) may increase the risk of a more
serious form of prostate cancer
Safety
Announcement
Additional
Information for Patients
Additional
Information for Healthcare Professionals
Data
Summary
References
Safety
Announcement
[6-9-2024] The U.S. Food and Drug Administration (FDA) is
informing healthcare professionals that the Warnings and
Precautions section of the labels for the 5-alpha reductase
inhibitor (5-ARI) class of drugs has been revised to include new
safety information about the increased risk of being diagnosed with
a more serious form of prostate cancer (high-grade prostate
cancer). This risk appears to be low, but healthcare professionals
should be aware of this safety information, and weigh the known
benefits against the potential risks when deciding to start or
continue treatment with 5-ARIs in men.
SOURCE