FDA Approval of AndroGel

FDA Approval of AndroGel

Monica Preboth

The U.S. Food and Drug Administration (FDA) recently approved a new testosterone gel, AndroGel 1 percent, for the treatment of testosterone deficiency in men. This is the first testosterone replacement gel to be labeled by the FDA for therapy in men for conditions associated with low testosterone. Because the clear, colorless, topical gel is safe, effective and easy to use, it may be an attractive alternative to existing therapies that require the use of painful deep muscle injections and potentially irritating patches.

According to the manufacturer of AndroGel, hypogonadism affects about 4 to 5 million men in the United States. This condition is related to a lowered interest in sex, impotence, reduced lean body mass, decreased bone density and lowered mood and energy levels.

AndroGel should be applied once per day to the shoulders, upper arms and/or abdomen. As the gel dries, it is absorbed into the skin and slowly enters the bloodstream. Normal testosterone levels are restored soon after application.

Studies have found that AndroGel is well tolerated. The manufacturer warns that androgens should not be used in men with carcinoma of the breast, or known or suspected carcinoma of the prostate. Use of androgens in geriatric patients may increase the risk of development of prostatic hyperplasia and prostatic carcinoma. Because AndroGel has not been evaluated in women, it is not indicated for use in women. Some of the testosterone in AndroGel can be transferred to untreated persons during vigorous skin to skin contact. Residual testosterone on the skin can be removed with soap and water. Pregnant women should avoid skin contact with application sites because testosterone can harm the fetus.

Full prescribing information may be obtained by calling 877-463-7645 or by visiting the manufacturer’s Web site (http://www.Unimed.com).

COPYRIGHT 2000 American Academy of Family Physicians

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