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Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving Avodart and at a higher incidence than subjects receiving placebo. Therefore, Avodart may cause fetal harm when administered to a pregnant woman. The relationship between long-term use of Avodart and male breast neoplasia is currently unknown. Most of the 4,844 subjects randomly assigned to receive combination, Avodart, or tamsulosin completed 2 years of double-blind treatment (79%, 80%, and 78%, respectively). If Avodart is used during pregnancy or if the patient becomes pregnant while taking Avodart, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5. Avodart is a 5α-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia.

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