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FDA Issues Warning for Serious Effects From Children in Contact with Users of Testosterone Gel

Young children are reportedly developing premature or inappropriate sexual organs from their contact with adult users of testosterone gel. Specifically, young girls developed male sex characteristics, and boys prematurely developed male sex characteristics. The FDA is now requiring two testosterone gel products to have a boxed label warning of these serious side effects.

The gels in question, AndroGel and Testim, are approved for use in men who have extremely low testosterone levels. Women reportedly use testosterone gel to increase libido; this is an off-label, non-FDA approved use of testosterone gel and not recommended. In 2007, there were 1.4 million prescriptions dispensed for AndroGel and just 370,000 for Testim.

AndroGel is manufactured by Solvay of Belgium. Testim is manufactured by Auxilium of Malvern, PA.

Dr. Dianne Murphy, director of the Office of Pediatric Therapeutics at the FDA, suggests that a gel user could have caused the child to come into contact with the gel by forgetting to wash his or her hands or the treated area. Additionally, the gel user may have not waited for skin to dry, and then picked up the child and held him or her.

Children ages 9 months to 5 years are among the eight reported cases the FDA is following. These children suffer from abnormal effects, including inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido and aggressive behavior.

Most of the children’s signs and symptoms regressed after they were no longer exposed to the gel. However, a few children still have enlarged genitalia and bone ages higher than the child’s chronological age, the FDA said.

One of these children required surgical intervention. Some children also had to undergo invasive diagnostic procedures.

More than a dozen additional reported cases are currently under review by FDA.
The current labels of the two gel products instruct users to wash their hands after use, and to cover treated skin with clothing.

When product users applied gel to body parts that were not indicated in the product’s labeling, they “increased the opportunity for a child to be inadvertently exposed,” Murphy said.
The FDA recommends that children and women avoid contact with the places where men have applied these products. The agency also recommends that adults who use testosterone gels always do the following:

• Wash hands with soap and water after every application.• Wash the site where the gel was applied with soap and water before coming into skin contact with another person, especially children.

• Cover the application site with clothing when gel has dried.

• Note that the use of non-FDA-approved testosterone gels that can result the same effects should be avoided.

Health care professional and consumers are urged to contact the FDA with adverse event or product quality issues with the contact information below.

–Online: www.fda.gov/MedWatch/report.htm
–Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
–Fax: (800) FDA-0178
–Phone: (800) FDA-1088

For more information please see: http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html

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