Clinical trials of Avodart showed that it was generally well tolerated. Most side effects were mild or moderate and generally went away while on treatment in both the Avodart and placebo groups.

Drug-related side effects during the first six months were as follows: impotence (4.7 percent vs. 1.7 percent for placebo), decreased libido (3 percent vs. 1.4 percent), breast tenderness and breast enlargement (gynecomastia; 0.5 percent vs. 0.2 percent) and ejaculation disorders (1.4 percent vs. 0.5 percent). The incidence of most drug-related sexual side effects decreased with duration of treatment. The incidence of drug-related breast tenderness and breast enlargement remained constant over the treatment period. Ejaculate volume may be decreased in some patients with continued treatment. This decrease did not appear to interfere with normal sexual function.

- Avodart should not be used in women and children. Women who are pregnant or may become pregnant should not handle Avodart because of possibility of absorption of Avodart and subsequent potential risk to a male fetus.

- Men treated with Avodart should not donate blood until at least six months after their final dose to prevent giving Avodart to a pregnant woman through a blood transfusion. Men with an allergic reaction to Avodart or its ingredients should not take it. Men with liver disease should talk to their doctor before taking Avodart.

- Avodart will reduce the amount of PSA measured in the blood. A physician will be aware of this effect and can still use PSA to detect prostate cancer.

The recommended dose of Avodart is a 0.5 mg soft gelatin capsule taken once daily.

Avodart is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve urinary symptoms, reduce risk of acute urinary retention and reduce the risk of the need for BPH-related surgery.

Avodart will be available for prescription in December 2002.