Other safety alerts
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| The United States: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer |
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The U.S. Food and Drug Administration (FDA) notified healthcare professionals that 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. The new safety information is based on FDA’s review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Proscar (finasteride), Avodart (dutasteride), and Jalyn (dutasteride, tamsulosin HCl), are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is approved to treat male pattern hair loss. Prior to initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH).
Please refer to the following website in the FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258529.htm
In Hong Kong, products which are 5-alpha reductase inhibitor (5-ARI) class of drug, finasteride and dutasteride, are registered. There are 18 finasteride-containing products (including Proscar and Propecia) registered. For dutasteride, only Avodart is registered. All these 5-alpha reductase inhibitor products are prescription drug. In light of the new information, the issue will be discussed in the next meeting of Registration Committee of the Pharmacy and Poisons Board. A “Dear Healthcare Professional” letter will be issued.
Ends/Friday, June 10, 2011
Issued at HKT 12:00
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