Teva Pharmaceutical Industries has received approval and launched, in the United States, a generic version of the Avodart (dutasteride) capsules at the 0.5 mg dose. Avodart, 5-alpha reductase inhibitor, is FDA approved for the treatment of men with benign prostate hyperplasia (an enlarged prostate gland), however, although not approved; men often use it as a part of their hormone therapy treatment protocol (ADT).
The use of Avodart as an ADT drug is controversial with more support from doctors on the west coast than on the east coast. The best-known exception to this is Dr. S. Meyers (east coast) who has pioneered many of the off label prostate cancer treatments, including the use of Avodart as a significant part of ADT.
The actual evidence supporting the use of Avodart as an ADT drug is mixed. Avodart does reduce, by approximately 50%, a man’s prostate specific antigen (PSA) score, but it is unclear if the PSA reduction is simply a result of the shrinkage of the prostate gland itself (or in the case of men post surgery who still have some left-over prostate cells), or the actual reduction of the activity of the cancer.
In 2011 the FDA issued a warning to physicians that there is an increased risk of a man developing high-grade prostate cancer with the use of 5-alpha reductase inhibitors, of which Avodart is one. In fairness, this risk is very small, but a man needs to consider it when deciding if Avodart should be a part of their ADT protocol.
Those men taking Avodart should ask their doctors if their next prescription for Avodart should be filled with the generic version.