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Proscar FDA Alerts

The FDA Alerts below may be specifically about Proscar or relate to a group or class of drugs which include Proscar.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Proscar

5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer

Jun 9, 2011 | Audience: Urology, Family Medicine, Internal Medicine

Drugs in the 5-ARI class include finasteride and dutasteride. These drugs are marketed under the brand-names Proscar, Propecia, Avodart, and Jalyn

ISSUE: FDA notified 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).

BACKGROUND: 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, Avodart, and Jalyn 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.

RECOMMENDATION: 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). See Drug Safety Communication for a Data Summary and additional information.


Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[06/09/2011 - Drug Safety Communication - FDA]

Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling

Mar 28, 2011 | Audience: Risk Manager, Pharmacy, Family Practice

ISSUE: Greenstone LLC announced a recall of medicines with lot number FI0510058-A on the label. Bottles labeled as Citalopram (used to treat depression) may contain Finasteride (used for the treatment of benign prostatic hyperplasia). Women who are, or may become pregnant, should not take or handle Finasteride due to the possible risk of side effects which may cause abnormalities to the external genitalia of a developing male fetus. Citalopram is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or pimozide; it is also contraindicated in patients with a hypersensitivity to Citalopram or any of the inactive ingredients in the tablet. Patients who discontinue Citalopram abruptly by inadvertently taking the mislabeled product may experience discontinuation symptoms and/or worsening of depression.

BACKGROUND: This includes Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle), both distributed in the U.S. market. The recall is due to the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer.

RECOMMENDATION: Bottles of either Citalopram or Finasteride with lot number FI050058-A should be returned. Patients who believe they may have ingested the wrong medication should contact their physician as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[03/26/2011 - Press Release - Greenstone]

    

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