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U.S. Department of Health and Human Services


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Avodart (dutasteride) soft gelatin capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –  June 2010, June 2011 and June 2012


June 2012

Summary View



Evaluation for Other Urological Diseases
  • Prior to initiating treatment with Avodart, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist.


June 2011

Summary View



Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection
  • In clinical studies, Avodart reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. This decrease was predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. Avodart may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men taking Avodart, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on Avodart may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5 alpha reductase inhibitor. Noncompliance with Avodart may also affect PSA test results.
  • To interpret an isolated PSA value in a man treated with Avodart for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men.
  • The free-to-total PSA ratio (percent free PSA) remains constant, even under the influence of Avodart. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men receiving Avodart, no adjustment to its value appears necessary.
  • Coadministration of dutasteride and tamsulosin resulted in similar changes to serum PSA as dutasteride monotherapy.
Increased Risk of High-grade Prostate Cancer
  • In men aged 50 to 75 years with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng/mL and 10.0 ng/mL taking Avodart in the 4-year Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (Avodart 1.0% versus placebo 0.5%) [see Indications and Usage (1.3), Adverse Reactions (6.1)]. In a 7-year placebo-controlled clinical trial with another
  • 5 alpha-reductase inhibitor (finasteride 5 mg, PROSCAR), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%). 5 alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5 alpha-reductase inhibitors to reduce prostate volume, or study related factors, impacted the results of these studies has not been established.


June 2010

Summary View



Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection 
  • Any confirmed increases in PSA levels from nadir while on Avodart may signal the presence of prostate cancer and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5-alpha reductase inhibitor. 


Cardiac Failure
  • In CombAT, after 4 years of treatment, the incidence of the composite term cardiac failure in the combination therapy group (12/1,610; 0.7%) was higher than in either monotherapy group: Avodart, 2/1,623 (0.1%) and tamsulosin, 9/1,611 (0.6%). Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating Avodart in men at risk for development of prostate cancer. The incidence of cardiac failure in subjects taking Avodart was 0.6% (26/4,105) compared to 0.4% (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both studies had co-morbidities associated with an increased risk of cardiac failure. Therefore, the clinical significance of the numerical imbalances in cardiac failure is unknown. No causal relationship between Avodart, alone or in combination with tamsulosin, and cardiac failure has been established. No imbalance was observed in the incidence of overall cardiovascular adverse events in either study.

Patient Information

General information about Avodart
  • Increases in your PSA levels from their lowest point while on treatment with Avodart (even if the PSA values are in the normal range) should be evaluated by your physician.