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FDA Approves GlaxoSmithKline's AVODART(R) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate
Date:6/19/2008

th the alpha blocker tamsulosin for the treatment of symptomatic enlarged prostate. While some men have fewer problems and symptoms after three months of treatment with AVODART, a treatment period of at least six months is usually necessary to see if AVODART will improve symptoms.

Only a healthcare provider can tell if symptoms are from an enlarged prostate and not a more serious condition such as prostate cancer. Men should see their doctors for regular exams. Children and women who are or may become pregnant should not take AVODART. Women who are or may become pregnant should not handle AVODART. Men treated with AVODART should not donate blood until at least six months after their final dose.

Caution should be used in patients with liver disease. Possible side effects include sexual side effects and breast tenderness and/or swelling. These side effects occur infrequently. For full prescribing information, see http://www.avodart.com.

About Enlarged Prostate

Enlarged prostate is a prevalent and progressive disease that affects 50 percent of men over 50 years of age and over 90 percent of men older than age 80.1 An enlarged prostate causes changes in urinary habits because of its location around the urethra. Over time, the prostate can continue to grow and urinary symptoms may worsen as the bladder loses the ability to empty itself. Left untreated, in severe cases, an enlarged prostate can lead to serious long-term problems including acute urinary retention (AUR) and the need for prostate-related surgery, and in rare cases even kidney or bladder damage.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Company information line: 1-888-825-5249. Website address: '/>"/>

SOURCE GlaxoSmithKline
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